propofol has been researched along with Adverse Drug Event in 25 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.
| Excerpt | Relevance | Reference |
|---|---|---|
| "To investigate biochemically whether total intravenous anesthesia (TIVA) using propofol creates a risk for Propofol Infusion Syndrome (PRIS)." | 9.17 | Biochemical markers in total intravenous anesthesia and propofol infusion syndrome: a preliminary study. ( Gürses, E; Oztürk, I; Serin, S, 2013) |
| "Sugammadex (Org 25969), a novel, selective relaxant binding agent, was specifically designed to rapidly reverse rocuronium-induced neuromuscular blockade." | 9.13 | Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. ( Claudius, C; Eikermann, M; Khuenl-Brady, KS; Larsen, PB; Prins, ME; Pühringer, FK; Rex, C; Sielenkämper, AW, 2008) |
| "In non-intubated general anesthesia, the combination of subclinical doses of esketamine and propofol did reduce circulatory and respiratory depression, injection pain, and other adverse effects, while the incidence of esketamine's own side effects such as neuropsychiatric reactions did not increase, and the combination of the two did not cause the occurrence of new and more serious adverse reactions, and the combination of the two was safe and effective." | 5.41 | Analysis of the efficacy of subclinical doses of esketamine in combination with propofol in non-intubated general anesthesia procedures - a systematic review and meta-analysis. ( Chen, H; Ding, X; Fu, Q; Li, P; Liu, Q; Xiang, G; Xu, L, 2023) |
| "To investigate biochemically whether total intravenous anesthesia (TIVA) using propofol creates a risk for Propofol Infusion Syndrome (PRIS)." | 5.17 | Biochemical markers in total intravenous anesthesia and propofol infusion syndrome: a preliminary study. ( Gürses, E; Oztürk, I; Serin, S, 2013) |
| "Sugammadex (Org 25969), a novel, selective relaxant binding agent, was specifically designed to rapidly reverse rocuronium-induced neuromuscular blockade." | 5.13 | Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. ( Claudius, C; Eikermann, M; Khuenl-Brady, KS; Larsen, PB; Prins, ME; Pühringer, FK; Rex, C; Sielenkämper, AW, 2008) |
| "The meta-analysis currently generates the evidence of combination of propofol with the dosage of 0." | 3.01 | Propofol decreased the etomidate-induced myoclonus in adult patients: a meta-analysis and systematic review. ( Chang, P; Chen, XB; Feng, Y; Zhang, WS; Zhang, YL, 2023) |
| "Propofol was administered by bolus injection, with a standard protocol of 40 mg for patients <70 years old, 30 mg for patients 70-89 years old, and 20 mg for patients 90 years or older." | 2.74 | Low-dose propofol sedation for diagnostic esophagogastroduodenoscopy: results in 10,662 adults. ( Hidaka, N; Horiuchi, A; Ichise, Y; Kajiyama, M; Nakayama, Y; Tanaka, N, 2009) |
| "Propofol is an addictive drug, and the problem of its abuse and dependence has occurred." | 1.42 | Increased use in propofol and reported patterns of adverse events among anesthetics in Korea. ( Kim, MH; Park, BJ; Park, HJ; Shin, JY, 2015) |
| " The extent to which clinicians follow established dosing guidelines has not been well described." | 1.42 | Propofol Use in the Elderly Population: Prevalence of Overdose and Association With 30-Day Mortality. ( Andreopoulos, E; Deiner, S; Levin, MA; Mo Lin, H; Phillips, AT; Silverstein, J, 2015) |
| "To evaluate the nature, frequency, and predictors of adverse events during the use of propofol by pediatric hospitalists." | 1.38 | Procedural sedation for diagnostic imaging in children by pediatric hospitalists using propofol: analysis of the nature, frequency, and predictors of adverse events and interventions. ( Carlson, DW; Depalma, LM; Mao, J; Srinivasan, M; Turmelle, M, 2012) |
| " Primary outcomes were serious adverse events, sedation events, and efficacy." | 1.37 | Safety and efficacy of procedural sedation with propofol in a country with a young emergency medicine training program. ( Dijksman, LM; Kok, MF; Kuypers, MI; Mencl, F; Simons, MP; Verhagen, MF, 2011) |
| "57% of patients having complications (52 patients having 60 adverse events)." | 1.37 | Safety of intravenous sedation administered by the operating oral surgeon: the second 7 years of office practice. ( Rodgers, MS; Rodgers, SF, 2011) |
| "5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects." | 1.32 | Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling. ( Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 1 (4.00) | 18.2507 |
| 2000's | 5 (20.00) | 29.6817 |
| 2010's | 13 (52.00) | 24.3611 |
| 2020's | 6 (24.00) | 2.80 |
| Authors | Studies |
|---|---|
| Matthews, EJ | 1 |
| Kruhlak, NL | 1 |
| Weaver, JL | 1 |
| Benz, RD | 1 |
| Contrera, JF | 1 |
| Liu, Z | 1 |
| Shi, Q | 1 |
| Ding, D | 1 |
| Kelly, R | 1 |
| Fang, H | 1 |
| Tong, W | 1 |
| De Vico, P | 3 |
| Cammalleri, V | 3 |
| Marchei, M | 3 |
| Macrini, M | 3 |
| Lecis, D | 3 |
| Idone, G | 3 |
| Massaro, G | 3 |
| Di Landro, A | 3 |
| Zingaro, A | 3 |
| Di Luozzo, M | 3 |
| Prandi, FR | 3 |
| Ussia, GP | 3 |
| Romeo, F | 3 |
| Dauri, M | 3 |
| Muscoli, S | 3 |
| Feng, Y | 1 |
| Chen, XB | 1 |
| Zhang, YL | 1 |
| Chang, P | 1 |
| Zhang, WS | 1 |
| Chen, H | 1 |
| Ding, X | 1 |
| Xiang, G | 1 |
| Xu, L | 1 |
| Liu, Q | 1 |
| Fu, Q | 1 |
| Li, P | 1 |
| Shimizu, H | 1 |
| Homma, Y | 1 |
| Norii, T | 1 |
| Bulut, O | 1 |
| Ovali, F | 1 |
| Takahashi, K | 1 |
| Ricci, F | 1 |
| Lunghi, F | 1 |
| De Simone, C | 1 |
| Peris, K | 1 |
| Frieling, T | 1 |
| Heise, J | 1 |
| Kreysel, C | 1 |
| Kuhlen, R | 1 |
| Schepke, M | 1 |
| Wutzler, A | 1 |
| Loehr, L | 1 |
| Huemer, M | 1 |
| Parwani, AS | 1 |
| Steinhagen-Thiessen, E | 1 |
| Boldt, LH | 1 |
| Haverkamp, W | 1 |
| Oztürk, I | 1 |
| Serin, S | 1 |
| Gürses, E | 1 |
| Park, HJ | 1 |
| Shin, JY | 1 |
| Kim, MH | 1 |
| Park, BJ | 1 |
| Phillips, AT | 1 |
| Deiner, S | 1 |
| Mo Lin, H | 1 |
| Andreopoulos, E | 1 |
| Silverstein, J | 1 |
| Levin, MA | 1 |
| Pühringer, FK | 1 |
| Rex, C | 1 |
| Sielenkämper, AW | 1 |
| Claudius, C | 1 |
| Larsen, PB | 1 |
| Prins, ME | 1 |
| Eikermann, M | 1 |
| Khuenl-Brady, KS | 1 |
| Lee, JS | 1 |
| Gonzalez, ML | 1 |
| Chuang, SK | 1 |
| Perrott, DH | 1 |
| Horiuchi, A | 1 |
| Nakayama, Y | 1 |
| Hidaka, N | 1 |
| Ichise, Y | 1 |
| Kajiyama, M | 1 |
| Tanaka, N | 1 |
| Devlin, JW | 1 |
| Mallow-Corbett, S | 1 |
| Riker, RR | 1 |
| Kiringoda, R | 1 |
| Thurm, AE | 1 |
| Hirschtritt, ME | 1 |
| Koziol, D | 1 |
| Wesley, R | 1 |
| Swedo, SE | 1 |
| O'Grady, NP | 1 |
| Quezado, ZM | 1 |
| Kuypers, MI | 1 |
| Mencl, F | 1 |
| Verhagen, MF | 1 |
| Kok, MF | 1 |
| Dijksman, LM | 1 |
| Simons, MP | 1 |
| Rodgers, SF | 1 |
| Rodgers, MS | 1 |
| Srinivasan, M | 1 |
| Turmelle, M | 1 |
| Depalma, LM | 1 |
| Mao, J | 1 |
| Carlson, DW | 1 |
| Cravero, JP | 1 |
| Polo-Romero, FJ | 1 |
| Graystone, S | 1 |
| Wells, MF | 1 |
| Farrell, DJ | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| The Effect of High-flow Nasal Oxygenation vs. Low-flow Nasal Oxygenation on Oxygen Saturation During Analgo-sedation in Obese Adult Patients, Randomized Controlled Trial[NCT03687424] | 126 participants (Anticipated) | Interventional | 2018-10-30 | Not yet recruiting | |||
| Effect of High-flow vs. Low-flow Nasal Oxygenation on Spontaneous Ventilation in Obese Adult Patients During Analgo-sedation for Vitrectomy, Randomized Controlled Trial[NCT04049240] | 126 participants (Anticipated) | Interventional | 2019-08-01 | Recruiting | |||
| Effect of Deep Curarisation and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity in Patients Undergoing Laparoscopic Gastric Bypass Surgery[NCT01748643] | Phase 4 | 60 participants (Actual) | Interventional | 2013-04-30 | Completed | ||
| Dose Finding Study for Sugammadex and Neostigmine at Residual Neuromuscular Blockade (T4/T1 = 0.5)[NCT00895609] | Phase 4 | 99 participants (Actual) | Interventional | 2009-03-31 | Completed | ||
| Small Dose of Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery (TOF 0.9)[NCT01101139] | Phase 4 | 300 participants (Actual) | Interventional | 2010-04-30 | Completed | ||
| Dose Finding Study for Sugammadex and Neostigmine at Residual Neuromuscular Blockade (T4/T1 = 0.2)[NCT01006720] | 99 participants (Actual) | Observational | 2009-03-31 | Completed | |||
| A Randomized, Blinded-assessor, Single Center Study to Determine if Administration of Sugammadex, When Used to Reverse Deep Neuromuscular Blockade (NMB) After Open Abdominal Surgery, Impacts Hospital Efficiency[NCT02860507] | Phase 4 | 50 participants (Actual) | Interventional | 2016-08-31 | Completed | ||
| Neuromuscular Blockade Improves Surgical Conditions[NCT00895778] | 57 participants (Actual) | Interventional | 2009-03-31 | Completed | |||
| A Multi-Center, Randomized, Safety Assessor-Blinded, Placebo- Controlled, Phase II, Parallel Dose-Finding Trial in Subjects of ASA 1-3 to Assess the Efficacy and Safety of 5 Doses of Sugammadex Administered at 3 and 15 Minutes After Administration of 1.0 [NCT00535743] | Phase 2 | 174 participants (Actual) | Interventional | 2004-03-04 | Completed | ||
| Radiation-Free Heart Catheterization Using MRI[NCT02739087] | 50 participants (Anticipated) | Interventional | 2015-03-31 | Active, not recruiting | |||
| MRI Assessment of Arrythmia Ablation Lesions[NCT02761343] | 16 participants (Actual) | Interventional | 2014-04-30 | Completed | |||
| XFM: (X-ray Fused With MRI) Guided Cardiac Catheterization[NCT02737579] | 27 participants (Actual) | Interventional | 2013-07-23 | Active, not recruiting | |||
| [NCT01855581] | 3,739 participants (Anticipated) | Observational | 2012-11-30 | Recruiting | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
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
| Intervention | minutes (Mean) |
|---|---|
| Deep Neuromuscular Blockade, Reversal With Sugammadex | 61.3 |
| Normal Neuromuscular Blockade, Reversal With Neostigmine | 70.6 |
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))
| Intervention | percent change from baseline (Mean) |
|---|---|
| Deep Neuromuscular Blockade, Reversal With Sugammadex | 45.2 |
| Normal Neuromuscular Blockade, Reversal With Neostigmine | 48.8 |
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))
| Intervention | percent change from baseline (Mean) |
|---|---|
| Deep Neuromuscular Blockade, Reversal With Sugammadex | 51.9 |
| Normal Neuromuscular Blockade, Reversal With Neostigmine | 49.0 |
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
| Intervention | number of intra-abdominal pressure rises (Mean) |
|---|---|
| Deep Neuromuscular Blockade, Reversal With Sugammadex | 0.2 |
| Normal Neuromuscular Blockade, Reversal With Neostigmine | 0.3 |
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))
| Intervention | percent change from baseline (Mean) |
|---|---|
| Deep Neuromuscular Blockade, Reversal With Sugammadex | 51.3 |
| Normal Neuromuscular Blockade, Reversal With Neostigmine | 51.5 |
"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
| Intervention | units on a scale (Mean) |
|---|---|
| Deep Neuromuscular Blockade, Reversal With Sugammadex | 4.2 |
| Normal Neuromuscular Blockade, Reversal With Neostigmine | 3.9 |
(NCT02860507)
Timeframe: through discharge from hospital, average of 72 hours
| Intervention | Participants (Count of Participants) |
|---|---|
| Neostigmine + Glycopyrrolate | 8 |
| Sugammadex | 10 |
(NCT02860507)
Timeframe: through start of next surgery, average of 2 hours
| Intervention | Minutes (Mean) |
|---|---|
| Neostigmine + Glycopyrrolate | 49.7 |
| Sugammadex | 49.45 |
"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
| Intervention | minutes (Mean) |
|---|---|
| Arm A. Placebo; 3 Min After 1 mg/kg Esmeron® | 91.58 |
| Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 36.43 |
| Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 4.55 |
| Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 1.58 |
| Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 1.13 |
| Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 1.27 |
| Arm G. Placebo; 15 Min After 1 mg/kg Esmeron® | 81.70 |
| Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 5.28 |
| Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 3.28 |
| Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 1.25 |
| Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 1.28 |
| Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 0.93 |
| Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron® | 122.90 |
| Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 54.43 |
| Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 7.45 |
| Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 2.42 |
| Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 1.62 |
| Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 1.18 |
| Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron® | 111.37 |
| Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 24.15 |
| Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 3.08 |
| Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 1.58 |
| Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 1.67 |
| Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 1.22 |
"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
| Intervention | minutes (Mean) |
|---|---|
| Arm A. Placebo; 3 Min After 1 mg/kg Esmeron® | 98.23 |
| Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 40.00 |
| Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 5.90 |
| Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 1.87 |
| Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 1.57 |
| Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 1.43 |
| Arm G. Placebo; 15 Min After 1 mg/kg Esmeron® | 91.53 |
| Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 6.23 |
| Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 4.10 |
| Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 1.45 |
| Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 1.33 |
| Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 0.93 |
| Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron® | 129.85 |
| Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 60.85 |
| Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 8.52 |
| Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 2.80 |
| Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 1.73 |
| Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 1.20 |
| Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron® | 121.03 |
| Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 33.95 |
| Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 4.42 |
| Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 1.98 |
| Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 1.72 |
| Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 1.27 |
"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
| Intervention | minutes (Mean) |
|---|---|
| Arm A. Placebo; 3 Min After 1 mg/kg Esmeron® | 108.43 |
| Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 44.73 |
| Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 6.93 |
| Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 2.40 |
| Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 2.42 |
| Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 1.77 |
| Arm G. Placebo; 15 Min After 1 mg/kg Esmeron® | 127.37 |
| Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 8.53 |
| Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 5.47 |
| Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 1.85 |
| Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 1.78 |
| Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 0.93 |
| Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron® | 122.98 |
| Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 65.67 |
| Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 13.78 |
| Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 3.23 |
| Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 2.08 |
| Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 1.32 |
| Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron® | 139.62 |
| Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 42.20 |
| Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 5.97 |
| Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 2.33 |
| Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 1.77 |
| Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 4.73 |
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
| Intervention | Participants (Count of Participants) |
|---|---|
| Arm A. Placebo; 3 Min After 1 mg/kg Esmeron® | 5 |
| Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 5 |
| Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 7 |
| Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 7 |
| Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 8 |
| Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | 7 |
| Arm G. Placebo; 15 Min After 1 mg/kg Esmeron® | 2 |
| Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 4 |
| Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 3 |
| Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 4 |
| Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 3 |
| Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | 4 |
| Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron® | 3 |
| Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 5 |
| Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 7 |
| Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 5 |
| Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 6 |
| Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | 9 |
| Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron® | 3 |
| Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 2 |
| Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 4 |
| Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 1 |
| Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 3 |
| Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | 3 |
4 reviews available for propofol and Adverse Drug Event
| Article | Year |
|---|---|
Propofol decreased the etomidate-induced myoclonus in adult patients: a meta-analysis and systematic review.
Topics: Adult; Anesthesia, General; Drug-Related Side Effects and Adverse Reactions; Etomidate; Humans; Myoc | 2023 |
Analysis of the efficacy of subclinical doses of esketamine in combination with propofol in non-intubated general anesthesia procedures - a systematic review and meta-analysis.
Topics: Anesthesia, General; Drug-Related Side Effects and Adverse Reactions; Humans; Ketamine; Pain; Propof | 2023 |
[Examples of Malfunction Occurred by Interactions between Pharmaceutical Products and Medical Devices That Pharmacists Should Be Aware of].
Topics: Amiodarone; Awareness; Defibrillators, Implantable; Drug-Related Side Effects and Adverse Reactions; | 2021 |
Adverse drug events associated with the use of analgesics, sedatives, and antipsychotics in the intensive care unit.
Topics: Acidosis; Analgesics; Antipsychotic Agents; Bradycardia; Cardiovascular Diseases; Critical Care; Dru | 2010 |
6 trials available for propofol and Adverse Drug Event
15 other studies available for propofol and Adverse Drug Event
| Article | Year |
|---|---|
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Topics: Adverse Drug Reaction Reporting Systems; Artificial Intelligence; Computers; Databases, Factual; Dru | 2004 |
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
Topics: Animals; Anti-Infective Agents; Anti-Inflammatory Agents; Chemical and Drug Induced Liver Injury; Da | 2011 |
Target-controlled infusion during MitraClip procedures in deep-sedation with spontaneous breathing.
Topics: Anesthesia, General; Drug-Related Side Effects and Adverse Reactions; Humans; Hypotension; Propofol; | 2022 |
Target-controlled infusion during MitraClip procedures in deep-sedation with spontaneous breathing.
Topics: Anesthesia, General; Drug-Related Side Effects and Adverse Reactions; Humans; Hypotension; Propofol; | 2022 |
Target-controlled infusion during MitraClip procedures in deep-sedation with spontaneous breathing.
Topics: Anesthesia, General; Drug-Related Side Effects and Adverse Reactions; Humans; Hypotension; Propofol; | 2022 |
Target-controlled infusion during MitraClip procedures in deep-sedation with spontaneous breathing.
Topics: Anesthesia, General; Drug-Related Side Effects and Adverse Reactions; Humans; Hypotension; Propofol; | 2022 |
Incidence of adverse events among elderly vs non-elderly patients during procedural sedation and analgesia with propofol.
Topics: Adult; Age Factors; Aged; Conscious Sedation; Drug-Related Side Effects and Adverse Reactions; Emerg | 2021 |
Green breast milk: A rare side effect of propofol.
Topics: Anesthetics, Intravenous; Animals; Drug-Related Side Effects and Adverse Reactions; Female; Humans; | 2021 |
Propofol-induced irreversible hair depigmentation: a case report.
Topics: Adolescent; Anesthetics, Intravenous; Drug-Related Side Effects and Adverse Reactions; Hair Color; H | 2017 |
Increased use in propofol and reported patterns of adverse events among anesthetics in Korea.
Topics: Adolescent; Adult; Adverse Drug Reaction Reporting Systems; Aged; Anesthetics, Intravenous; Child; C | 2015 |
Propofol Use in the Elderly Population: Prevalence of Overdose and Association With 30-Day Mortality.
Topics: Aged; Aged, 80 and over; Anesthetics, Intravenous; Drug-Related Side Effects and Adverse Reactions; | 2015 |
Risks of propofol sedation/anesthesia for imaging studies in pediatric research: eight years of experience in a clinical research center.
Topics: Adolescent; Child; Child, Preschool; Conscious Sedation; Diagnostic Imaging; Drug-Related Side Effec | 2010 |
Risks of propofol sedation/anesthesia for imaging studies in pediatric research: eight years of experience in a clinical research center.
Topics: Adolescent; Child; Child, Preschool; Conscious Sedation; Diagnostic Imaging; Drug-Related Side Effec | 2010 |
Risks of propofol sedation/anesthesia for imaging studies in pediatric research: eight years of experience in a clinical research center.
Topics: Adolescent; Child; Child, Preschool; Conscious Sedation; Diagnostic Imaging; Drug-Related Side Effec | 2010 |
Risks of propofol sedation/anesthesia for imaging studies in pediatric research: eight years of experience in a clinical research center.
Topics: Adolescent; Child; Child, Preschool; Conscious Sedation; Diagnostic Imaging; Drug-Related Side Effec | 2010 |
Risks of propofol sedation/anesthesia for imaging studies in pediatric research: eight years of experience in a clinical research center.
Topics: Adolescent; Child; Child, Preschool; Conscious Sedation; Diagnostic Imaging; Drug-Related Side Effec | 2010 |
Risks of propofol sedation/anesthesia for imaging studies in pediatric research: eight years of experience in a clinical research center.
Topics: Adolescent; Child; Child, Preschool; Conscious Sedation; Diagnostic Imaging; Drug-Related Side Effec | 2010 |
Risks of propofol sedation/anesthesia for imaging studies in pediatric research: eight years of experience in a clinical research center.
Topics: Adolescent; Child; Child, Preschool; Conscious Sedation; Diagnostic Imaging; Drug-Related Side Effec | 2010 |
Risks of propofol sedation/anesthesia for imaging studies in pediatric research: eight years of experience in a clinical research center.
Topics: Adolescent; Child; Child, Preschool; Conscious Sedation; Diagnostic Imaging; Drug-Related Side Effec | 2010 |
Risks of propofol sedation/anesthesia for imaging studies in pediatric research: eight years of experience in a clinical research center.
Topics: Adolescent; Child; Child, Preschool; Conscious Sedation; Diagnostic Imaging; Drug-Related Side Effec | 2010 |
Safety and efficacy of procedural sedation with propofol in a country with a young emergency medicine training program.
Topics: Abscess; Adolescent; Adult; Age Factors; Aged; Aged, 80 and over; Anesthetics, Intravenous; Child; D | 2011 |
Safety of intravenous sedation administered by the operating oral surgeon: the second 7 years of office practice.
Topics: Adult; Aged; Ambulatory Surgical Procedures; Anesthesia, Dental; Anesthetics, Intravenous; Conscious | 2011 |
Procedural sedation for diagnostic imaging in children by pediatric hospitalists using propofol: analysis of the nature, frequency, and predictors of adverse events and interventions.
Topics: Age Distribution; Child; Child, Preschool; Cohort Studies; Confidence Intervals; Conscious Sedation; | 2012 |
Pediatric sedation with propofol-continuing evolution of procedural sedation practice.
Topics: Conscious Sedation; Diagnostic Imaging; Drug-Related Side Effects and Adverse Reactions; Female; Hum | 2012 |
Propofol is not so safe for ERCP.
Topics: Abdominal Pain; Aged; Cholangiopancreatography, Endoscopic Retrograde; Conscious Sedation; Drug-Rela | 2006 |
Do intensive care drug infusions support microbial growth?
Topics: Anesthetics, Intravenous; Bacteria; Colony Count, Microbial; Critical Care; Drug Contamination; Drug | 1997 |