propofol and Neuromuscular Blockade

propofol has been researched along with Neuromuscular Blockade in 126 studies

Propofol: An intravenous anesthetic agent which has the advantage of a very rapid onset after infusion or bolus injection plus a very short recovery period of a couple of minutes. (From Smith and Reynard, Textbook of Pharmacology, 1992, 1st ed, p206). Propofol has been used as ANTICONVULSANTS and ANTIEMETICS.
propofol : A phenol resulting from the formal substitution of the hydrogen at the 2 position of 1,3-diisopropylbenzene by a hydroxy group.

Neuromuscular Blockade: The intentional interruption of transmission at the NEUROMUSCULAR JUNCTION by external agents, usually neuromuscular blocking agents. It is distinguished from NERVE BLOCK in which nerve conduction (NEURAL CONDUCTION) is interrupted rather than neuromuscular transmission. Neuromuscular blockade is commonly used to produce MUSCLE RELAXATION as an adjunct to anesthesia during surgery and other medical procedures. It is also often used as an experimental manipulation in basic research. It is not strictly speaking anesthesia but is grouped here with anesthetic techniques. The failure of neuromuscular transmission as a result of pathological processes is not included here.

Research

Studies (126)

Authors

Clinical Trials (45)

Trial Overview

Trial Outcomes

Electric Activity of the Diaphragm (Microvolts)

(NCT01962298)
Timeframe: From the start of spontaneous breathing till extubation, limited to maximum ten minutes after the onset of spontaneous breathing

Electric Activity of the Intercostal Muscles

(NCT01962298)
Timeframe: From the start of spontaneous breathing till extubation, limited to maximum ten minutes after the onset of spontaneous breathing

Incidence of Postoperative Residual Curarization

the number of participant with Postoperative residual curarization (PORC, TOF ratio < 0.9 ) (NCT03039543)
Timeframe: at the arrival of postoperative post-anesthesia care unit (PACU), an average of 5 minutes

Number of Participants Attaining a 5 (Optimal) Surgical Condition Score

"5-point surgical condition scale was evaluated as follows.~Extremely poor~unable to work because of coughing or because of the inability to obtain a endoscopic view because of inadequate muscle relaxation. Additional neuromuscular blocking agents (NMB) must be given.~Poor~severely hampered by inadequate muscle relaxation with continuous muscle contractions, movements, or both with the hazard of tissue damage. Additional NMB is needed.~Acceptable~a wide endoscopic view but bladder contractions, movements, or both occur regularly causing some interference with the surgeon's work. There is the need for additional NMB to prevent deterioration.~Good~a wide endoscopic working field with sporadic muscle contractions, movements, or both. No immediate need for additional NMB unless there is the fear of deterioration.~Optimal~a wide endoscopic working field without any movement or contractions. No additional NMB is needed." (NCT03039543)
Timeframe: immediately following the operation, an average of 5 minutes

Other Postoperative Adverse Events

Pain, postoperative nausea and vomiting, dry mouth, Postoperative bladder discomfort (NCT03039543)
Timeframe: During PACU stay (An average of 15 minutes)

Recovery Time (PACU Discharge)

time needed to reach a modified Aldrete score of 9 (NCT03039543)
Timeframe: During PACU stay (An average of 15 minutes)

the Incidence of Desaturation

Respiratory complication such as desaturation (SpO2 < 90%) were recorded during PACU stay. (NCT03039543)
Timeframe: During PACU stay (An average of 15 minutes)

Duration of Surgery

Measured from the time of first skin incision to completion of skin closure. (NCT01748643)
Timeframe: Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h

Forced Expiratory Volume in 1 Second

Forced expiratory volume in 1 second is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used. (NCT01748643)
Timeframe: Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))

Forced Vital Capacity

Forced vital capacity is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used. (NCT01748643)
Timeframe: Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))

Number of Intra-abdominal Pressure Rises > 18cmH2O

The number of intra-abdominal pressure rises > 18cmH2O detected by the intra-abdominal CO2 insufflator. (NCT01748643)
Timeframe: Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h

Peak Expiratory Flow

Peak expiratory flow is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used. (NCT01748643)
Timeframe: Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))

Subjective Evaluation of the View on the Operating Field by the Surgeon

"At the end of surgery, the view on the operating field will be graded by the surgeon using a 5-point rating scale:~Extremely poor~Poor~Acceptable~Good~Optimal" (NCT01748643)
Timeframe: Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h

Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications

(NCT02860507)
Timeframe: through discharge from hospital, average of 72 hours

Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate.

(NCT02860507)
Timeframe: through start of next surgery, average of 2 hours

Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7

"Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.7 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of NMB present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.7 indicates faster recovery from NMB. Summary data, originally presented in the format of units minutes:seconds (mm:ss), was reformatted to be presented in the single unit of minutes (min)." (NCT00535743)
Timeframe: Up to 180 minutes following administration of study treatment

Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8

"Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.8 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of NMB present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.8 indicates faster recovery from NMB. Summary data, originally presented in the format of units minutes:seconds (mm:ss), was reformatted to be presented in the single unit of minutes (min)." (NCT00535743)
Timeframe: Up to 200 minutes following administration of study treatment

Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9

"Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units minutes:seconds (mm:ss), was reformatted to be presented in the single unit of minutes (min)." (NCT00535743)
Timeframe: Up to 240 minutes following administration of study treatment

Number of Participants Experiencing an Adverse Event

The number of participants experiencing an adverse event (AE) was assessed. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. (NCT00535743)
Timeframe: Up to 7 days following administration of study treatment

Additional Rescue Doses Per Hour Ratio.

Additional Rescue Doses Per Hour Ratio is the number per hour of addition of rescue dose administrated with 10% of initial NMBAs dose. The formula is {(Addition number + 1 / Anesthetic time) x 60}. (NCT02495038)
Timeframe: Intraoperative, an average of 3 hours.

Anesthetic Time

Time from induction to recovery of anesthesia, asessed up to 3 hours. (NCT02495038)
Timeframe: Intraoperative, an average 4 hours.

Bispectral Index

"The BIS monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100. A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer.~Before induction of anesthesia, bispectral index was measured for baseline. And after injection of NMBAs, bispectral index was measured at 10 min." (NCT02495038)
Timeframe: Before and after induction of anesthesia, an average 10 min.

Body Temperature

"Before induction of anesthesia, body temperature was measured for baseline by oral temperature probe.~And after injection of NMBAs, non invasive blood pressure was measured at 10 min by esophageal temperature probe." (NCT02495038)
Timeframe: Before and after induction of anesthesia, an average 10 min.

Duration 25% of Neuromuscular Blocking Agents(NMBAs)

Time from administration of initial NMBAs to Train-of-four (TOF) ratio >25%, assessed up to 2 hours during general anesthesia. (NCT02495038)
Timeframe: Intraoperative, an average of 1 hours

Onset of Neuromuscular Blocking Agents(NMBAs)

Time from administration of initial NMBAs to Train-of-four (TOF) ratio=0, assessed up to 15 minutes during general anesthesia. (NCT02495038)
Timeframe: Intraoperative, an average of 5 minutes

Operation Time

Time from skin incision to wound dressing assessed up to 8 hours. (NCT02495038)
Timeframe: Intraoperative, an average of 3 hours.

Peripheral Oxygen Saturation

"Before induction of anesthesia, peripheral oxygen saturation was measured for baseline.~And after injection of NMBAs, peripheral oxygen saturation was measured at 10 min." (NCT02495038)
Timeframe: Before and after induction of anesthesia, an average 10 min.

Recovery Index of Neuromuscular Blocking Agents(NMBAs)

Time from TOF ratio 25% to 75%, assessed up to 1 hour during general anesthesia. (NCT02495038)
Timeframe: Intraoperative, an average of 20 minutes

Non Invasive Blood Pressure,

"Before induction of anesthesia, non invasive blood pressure was measured for baseline.~And after injection of NMBAs, non invasive blood pressure was measured at 10 min." (NCT02495038)
Timeframe: Before and after induction of anesthesia, an average 10 min.

Mean Time From Start Administration of Sugammadex to Recovery of Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9

Neuromuscular functioning was monitored by applying repetitive Train of Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 [loss of T4] up to 1.0 [no NMB]) indicates the extent of recovery from NMB. In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.9 indicates a faster recovery from NMB. (NCT00559468)
Timeframe: Up to 3 minutes after sugammadex administration

Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 [loss of T4] up to 1.0 [no NMB]) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.7 indicates a faster recovery from NMB. (NCT00559468)
Timeframe: Up to 3 minutes after sugammadex administration

Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 [loss of T4] up to 1.0 [no NMB]) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.8 indicates a faster recovery from NMB. (NCT00559468)
Timeframe: Up to 3 minutes after sugammadex administration

Clinical Duration

"The clinical duration is the elapsed time for T1 recovery = 25% (Dur25%) of the original value of T1 after the infusion of cisatracurium.~This outcome meansure was presented in minutes." (NCT02483611)
Timeframe: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes

Final Recovery Index

"The final recovery index is the elapsed time between the T1 recovery = 25% (Dur25%) and T4 / T1 = 80% (TOF = 80%) after the infusion of cisatracurium.~This outcome measure was presented in minutes." (NCT02483611)
Timeframe: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes

HR - M1 (Heart Rate in the Moment 1)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The measure of heart rate was recorded and annotated at various times such as in the arrival of the patient in the operating room. This time point was named as moment '1'. (NCT02483611)
Timeframe: This measure of heart rate was performed when the patient arrived in the operating room

HR - M2 (Heart Rate in the Moment 2)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as in the moment immediately before the anesthesia induction. This time point was named as moment '2'. (NCT02483611)
Timeframe: This measure of heart rate was performed immediately before induction of anesthesia

HR - M3 (Heart Rate in the Moment 3)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution). This time point was named as moment '3'. (NCT02483611)
Timeframe: This measure of heart rate was performed immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution)

HR - M4 (Heart Rate in the Moment 4)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as in the end of the study solutions infusion. This time point was named as moment '4'. (NCT02483611)
Timeframe: This measure of heart rate was performed five minutes after M3 (in the end of the X and Y solutions infusion)

HR - M5 (Heart Rate in the Moment 5)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as immediately before the tracheal intubation. This time point was named as moment '5'. (NCT02483611)
Timeframe: This measure of heart rate was performed immediately before the tracheal intubation

HR - M6 (Heart Rate in the Moment 6)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as one minute after the tracheal intubation. This time point was named as moment '6'. (NCT02483611)
Timeframe: This measure of heart rate was performed one minute after the tracheal intubation

HR - M7a (Heart Rate in the Moment 7a)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 15 minutes after the traqueal intubation.This time point was named as moment '7a'. (NCT02483611)
Timeframe: This measure of heart rate was performed 15 minutes after the traqueal intubation

HR - M7b (Heart Rate in the Moment 7b)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 30 minutes after the traqueal intubation. This time point was named as moment '7b'. (NCT02483611)
Timeframe: This measure of heart rate was performed 30 minutes after the traqueal intubation

HR - M7c (Heart Rate in the Moment 7c)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 45 minutes after the traqueal intubation. This time point was named as moment '7c'. (NCT02483611)
Timeframe: This measure of heart rate was performed 45 minutes after the traqueal intubation

HR - M7d (Heart Rate in the Moment 7d)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 60 minutes after the traqueal intubation. This time point was named as moment '7d'. (NCT02483611)
Timeframe: This measure of heart rate was performed 60 minutes after the traqueal intubation

HR - M7e (Heart Rate in the Moment 7e)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 75 minutes after the traqueal intubation. This time point was named as moment '7e'. (NCT02483611)
Timeframe: This measure of heart rate was performed 75 minutes after the traqueal intubation

HR - M7f (Heart Rate in the Moment 7f)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 90 minutes after the traqueal intubation. This time point was named as moment '7f'. (NCT02483611)
Timeframe: This measure of heart rate was performed 90 minutes after the traqueal intubation

Latency

"The latency is computed as the elapsed time to reduce the response of T1 to 5% of the initial contraction force after the infusion of cisatracurium.~This outcome meansure was presented in seconds." (NCT02483611)
Timeframe: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes

MAP - M1 (Mean Arterial Pressure in the Moment 1)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the arrival of the patient in the operating room. This time point was named as moment '1'. (NCT02483611)
Timeframe: This measure of average blood pressure was performed when the patient arrived in the operating room

MAP - M2 (Mean Arterial Pressure in the Moment 2)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the moment immediately before the anesthesia induction. This time point was named as moment '2'. (NCT02483611)
Timeframe: This measure of average blood pressure was performed immediately before induction of anesthesia

MAP - M3 (Mean Arterial Pressure in the Moment 3)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution). This time point was named as moment '3'. (NCT02483611)
Timeframe: This measure of average blood pressure was performed immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution)

MAP - M4 (Mean Arterial Pressure in the Moment 4)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the end of the study solutions infusion.This time point was named as moment '4'. (NCT02483611)
Timeframe: This measure of average blood pressure was performed five minutes after M3 (in the end of the X and Y solutions infusion)

MAP - M5 (Mean Arterial Pressure in the Moment 5)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as immediately before the tracheal intubation. This time point was named as moment '5'. (NCT02483611)
Timeframe: This measure of average blood pressure was performed immediately before the tracheal intubation

MAP - M6 (Mean Arterial Pressure in the Moment 6)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as one minute after the tracheal intubation. This time point was named as moment '6'. (NCT02483611)
Timeframe: This measure of average blood pressure was performed one minute after the tracheal intubation

MAP - M7a (Mean Arterial Pressure in the Moment 7a)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 15 minutes after the traqueal intubation. This time point was named as moment '7a'. (NCT02483611)
Timeframe: This measure of average blood pressure was performed 15 minutes after the traqueal intubation

MAP - M7b (Mean Arterial Pressure in the Moment 7b)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 30 minutes after the traqueal intubation. This time point was named as moment '7b'. (NCT02483611)
Timeframe: This measure of average blood pressure was performed 30 minutes after the traqueal intubation

MAP - M7c (Mean Arterial Pressure in the Moment 7c)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 45 minutes after the traqueal intubation. This time point was named as moment '7c'. (NCT02483611)
Timeframe: This measure of average blood pressure was performed 45 minutes after the traqueal intubation

MAP - M7d (Mean Arterial Pressure in the Moment 7d)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 60 minutes after the traqueal intubation. This time point was named as moment '7d'. (NCT02483611)
Timeframe: This measure of average blood pressure was performed 60 minutes after the traqueal intubation

MAP - M7e (Mean Arterial Pressure in the Moment 7e)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 75 minutes after the traqueal intubation. This time point was named as moment '7e'. (NCT02483611)
Timeframe: This measure of average blood pressure was performed 75 minutes after the traqueal intubation

MAP - M7f (Mean Arterial Pressure in the Moment 7f)

In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 90 minutes after the traqueal intubation. This time point was named as moment '7f'. (NCT02483611)
Timeframe: This measure of average blood pressure was performed 90 minutes after the traqueal intubation

Recovery Index

"The recovery index is the elapsed time between the T1 recovery =25% (Dur25%) and T1 =75% (Dur75%) after the infusion of cisatracurium.~This outcome meansure was presented in minutes." (NCT02483611)
Timeframe: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes

Spontaneous Recovery (T4/T1=90%)

"Spontaneous recovery is the elapsed time for the recovery of the TOF (T4 / T1) response to 90% of the original after infusion of cisatracurium.~This outcome measure was presented in minutes." (NCT02483611)
Timeframe: The participants were followed during the anesthetic - surgical procedure

Total Duration (Dur95%)

"The total duration is the elapsed time for T1 recovery of the response to reach 95% of the initial after the infusion of cisatracurium.~This outcome measure was presented in minutes." (NCT02483611)
Timeframe: Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes

Recovery Time of T1 to 90% Baseline

The time of neuromuscular recovery from sugammadex 4mg/kg dose reversal rocuronium at 0.6 mg/kg compared with traditionally used succinylcholine in electroconvulsive therapy (ECT). (NCT03532178)
Timeframe: 30 minutes

Number of Participants With Treatment or Emergent Adverse Events of the Drugs

To document the side-effect profiles of sugammadex reversal of rocuronium and succhinylcholine in the ECT patient population (NCT03532178)
Timeframe: 24 hours after the procedure

Monitoring of Clinical Signs of Recovery According to Routine Anesthetic Procedures at the Trial Sites

The monitoring of clinical signs of recovery was to be conducted based on the routine anesthetic procedures at each site. (NCT00724932)
Timeframe: Up to PACU discharge (up to ~4.5 hours)

Number of Female Participants or Partners of Male Participants Who Became Pregnant During Study

Thirty days after administration of IMP, female participants of childbearing potential were asked whether they became pregnant during the trial and male participants were asked whether their partner (if of childbearing potential) became pregnant during the trial. (NCT00724932)
Timeframe: Up to 30 days after IMP administration

Number of Participants With Clinical Evidence of Reoccurrence of Neuromuscular Blockade or Residual Neuromuscular Blockade (Routine Oxygen Saturation by Pulse Oximetry and Breath Frequency Measurement)

Clinical evidence of reoccurrence of NMB or residual NMB was assessed by oxygen saturation (by pulse oximetry) and breath frequency measurements as per routine practice after anesthesia and neuromuscular monitoring. (NCT00724932)
Timeframe: Up to 24 hours after IMP administration

Number of Participants With Events Due to a Possible Interaction of Sugammadex With Endogenous Compounds or With Exogenous Compounds Other Than Rocuronium

Any evidence of events due to a possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium, was to be recorded. (NCT00724932)
Timeframe: Up to 7 days after IMP administration

Number of Participants With Reoccurrence of Neuromuscular Blockade Based on the Train-of-Four- (TOF-) Watch® SX Recording (i.e. a Decline in T4/T1 Ratio From >=0.9 to <0.8 in at Least Three Consecutive TOF Values)

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the 1st and 4th twitches, respectively, after TOF stimulation. The T4/T1 Ratio is expressed as a decimal of up to 1.0. A higher ratio indicates greater recovery from NMB. A decline in the T4/T1 ratio from >=0.9 (indicating a recovery from NMB) to <0.8 for at least three consecutive TOF values was considered to be a reoccurrence of NMB. (NCT00724932)
Timeframe: Up to 30 minutes after IMP administration

Number of Participants With Train-of-Four- (TOF-) Watch® SX and Arm Board Related Adverse Events

Events were to be collected for the entire period of neuromuscular transmission monitoring and were defined as an occurrence that resulted or could have resulted in: death; a serious deterioration in the state of health of a user; an occurrence which might, if it recurred, lead to death or serious deterioration in health; inaccuracy as well as any inadequacy in the labeling or instructions which could cause misuse or incorrect maintenance or adjustment which might lead to a death or serious deterioration in health; an examination of the medical device or the information supplied with the medical device indicated some factor with the potential for an incident involving death or serious deterioration in health; malfunction or deterioration in characteristics and/or performance of a medical device, which might lead to death, or serious deterioration in health; technical/medical recalls involving risk of death or serious deterioration in the state of health of the user. (NCT00724932)
Timeframe: From induction of anesthesia to recovery from NMB (up to ~3 hours)

Time From Actual Operating Room Discharge to Actual PACU Discharge

The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU. (NCT00724932)
Timeframe: From actual Operating Room discharge to actual PACU discharge (up to ~4.4 hours)

Time From Actual Operating Room Discharge to PACU Discharge Ready

The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery. (NCT00724932)
Timeframe: From actual Operating Room discharge to PACU discharge ready (up to ~30 minutes)

Time From Operating Room Admission to Actual Operating Room Discharge

The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room. The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. (NCT00724932)
Timeframe: From Operating Room admission to actual Operating Room discharge (up to ~3 hours)

Time From Operating Room Admission to Operating Room Discharge Ready

The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of ≥0.9 and the participant's wound dressing was in place. (NCT00724932)
Timeframe: From Operating Room admission to Operating Room discharge ready (up to ~3 hours)

Time From Operating Room Discharge Ready to Actual Operating Room Discharge

The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. (NCT00724932)
Timeframe: From Operating Room discharge ready to actual Operating Room discharge (up to ~5 minutes)

Time From Operating Room Discharge Ready to Actual PACU Discharge

The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU. (NCT00724932)
Timeframe: From Operating Room discharge ready to actual PACU discharge (up to ~4.5 hours)

Time From Operating Room Discharge Ready to Post Anesthetic Care Unit (PACU) Discharge Ready

The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery. (NCT00724932)
Timeframe: From Operating Room discharge ready to PACU discharge ready (up to ~33 minutes)

Time From PACU Admit to Actual PACU Discharge

The time of PACU admit was defined as the actual time the participant was admitted to the PACU. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU. (NCT00724932)
Timeframe: From PACU admit to actual PACU discharge (up to ~4.3 hours)

Time From PACU Admit to PACU Discharge Ready

The time of PACU admit was defined as the actual time the participant was admitted to the PACU. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery. (NCT00724932)
Timeframe: From PACU admit to PACU discharge ready (up to ~25 minutes)

Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB. (NCT00724932)
Timeframe: From start of IMP administration to recovery of T4/T1 Ratio to 0.7 (ranging from ~2 minutes to ~5 minutes)

Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB. (NCT00724932)
Timeframe: From start of IMP administration to recovery of T4/T1 Ratio to 0.8 (ranging from ~2 minutes to ~6 minutes)

Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Neostigmine) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9

Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB. (NCT00724932)
Timeframe: From start of IMP administration to recovery of T4/T1 ratio to 0.9 (ranging from ~2 minutes to ~9 minutes)

Time From Start of Administration of the Last Dose of Rocuronium to the Time of 1-2 PTC in the 4.0 mg.Kg-1 Sugammadex Group

The time of 1-2 PTC refers to when 1-2 twitches are generated after tetanic stimulation. Time to 1-2 PTC is the time point of the last single twitch >0 or baseline (in case of noise or direct stimulation) within the sequence of a PTC measurement. 1-2 PTC was the target depth of NMB at which sugammadex was to be administered. (NCT00724932)
Timeframe: From last dose of rocuronium to 1-2 PTC (up to ~9 minutes)

Time From Start of Administration of the Last Dose of Rocuronium to the Time of Reappearance of T2 in the 50 μg.Kg-1 Neostigmine Group

The time of reappearance of T2 refers to when the second twitch reappears after TOF stimulation. Reappearance of T2 was the target depth of NMB at which neostigmine was to be administered. (NCT00724932)
Timeframe: From last dose of rocuronium to reappearance of T2 (up to ~26 minutes)

Time From Start of IMP Administration to Actual Operating Room Discharge

The time of IMP administration was defined as the actual time at which IMP administration was started. The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room. (NCT00724932)
Timeframe: From start of IMP administration to actual Operating Room discharge (up to ~26 minutes)

Time From Start of IMP Administration to Operating Room Discharge Ready

The time of IMP administration was defined as the actual time at which IMP administration was started. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. (NCT00724932)
Timeframe: From start of IMP administration to Operating Room discharge ready (up to ~21 minutes)

Time From Start of IMP Administration to Tracheal Extubation

The time of IMP administration was defined as the actual time at which IMP administration was started. The time of tracheal extubation was defined as the actual time at which the participant was extubated. (NCT00724932)
Timeframe: From start of IMP administration to tracheal extubation (up to ~21 minutes)

Time From Tracheal Extubation to Actual Operating Room Discharge

The time of tracheal extubation was defined as the actual time at which the participant was extubated. The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room. (NCT00724932)
Timeframe: From tracheal extubation to actual OR discharge (up to ~5 minutes)

Time From Tracheal Extubation to Operating Room Discharge Ready

The time of tracheal extubation was defined as the actual time at which the participant was extubated. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. (NCT00724932)
Timeframe: From tracheal extubation to Operating Room discharge ready (up to ~1 minute)

Mean Diastolic Blood Pressure

Diastolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery). (NCT00724932)
Timeframe: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)

Mean Heart Rate

Heart Rate was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery). (NCT00724932)
Timeframe: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)

Mean Systolic Blood Pressure

Systolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery). (NCT00724932)
Timeframe: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)

Number of Participants Who Experienced Pre-treatment Non-serious Adverse Events (AEs) and Post-treatment Non-serious AEs

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration. (NCT00724932)
Timeframe: From signing of informed consent to end of trial (7 days after surgery)

Number of Participants Who Experienced Pre-treatment Serious Adverse Events (SAEs) and Post-treatment SAEs

"An SAE is defined as any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.~Participants were monitored for occurrence SAEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration." (NCT00724932)
Timeframe: From signing of informed consent to end of trial (7 days after surgery)

Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.5 and 0.6

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). Faster times to recovery of the T4/T1 Ratios to 0.5 and 0.6 indicate faster recoveries from NMB. (NCT00724932)
Timeframe: From start of IMP administration to recovery of T4/T1 Ratio to 0.5 and 0.6 (ranging from ~1 minute to ~4 minutes)

Time From Start of Administration of the Last Dose of Rocuronium to Recovery of the T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio indicates a faster recovery from NMB. (NCT00724932)
Timeframe: From start of last dose of rocuronium to recovery of T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 (ranging from ~12 minutes to ~36 minutes)

Sugammadex ED90

"Complete reversal of neuromuscular blockade occured when the patient had a TOF T4/T1 ≥ 0.9 within eight minutes of sugammadex infusion.~The sequencial design method of up-and-down was applied to determine the minimum effective dose in 90% of patients (ED90). An effective dose is one that achieves complete reversal of neuromuscular blockade that is defined as a measure of TOF equal or higher than 0.9, or a relationship between T4 an T1 measure ≥ 0.9, within eight minutes of sugammadex infusion." (NCT02568345)
Timeframe: 8 minutes

Reviews

4 reviews available for propofol and Neuromuscular Blockade

Trials

65 trials available for propofol and Neuromuscular Blockade

Other Studies

57 other studies available for propofol and Neuromuscular Blockade