remimazolam and Hypotension

Remimazolam is a novel sedative drug that has been successively approved for procedural sedation and general anesthesia, however, which has not been fully explored due to limited clinical studies and a small sample size. Current clinical studies have focused on the use of remimazolam and propofol for general anesthesia (GA) as indicators of safety outcomes in surgical patients, but different studies have reached different conclusions. The aim of this study was to investigate whether the safety-related outcome indicators in GA were superior to propofol in surgical patients.. We systematically searched PubMed, Cochrane Library, Embase, and Web of Science databases for all published randomized controlled trials comparing remimazolam with propofol for general anesthesia. Data from eligible studies were pooled with relative risk or mean differences to analyze the differences in hemodynamic stability and adverse effects of the two medications.. Eight randomized controlled trials involving 998 participants were included. Compared with propofol, remimazolam had better hemodynamic stability with a lower incidence of hypotension (RR=0.43, 95% CI: [0.34, 0.55], I. In this Meta-analysis, compared with propofol, remimazolam for GA reduced the incidence of hypotension, hypoxemia, nausea and vomiting, dizziness and injection site pain, and had a more stable MAP before and after intubation, which supported that remimazolam is a safer sedative. However, a large sample is needed to validate this finding.

Topics: Anesthesia, General; Benzodiazepines; Dizziness; Humans; Hypnotics and Sedatives; Hypotension; Hypoxia; Nausea; Pain; Propofol; Randomized Controlled Trials as Topic; Vomiting

To improve patient tolerability and satisfaction as well as minimize complications, procedural sedation has been widely used. Propofol is the most widely used agent for induction of anesthesia and sedation by anesthesiologists. With a different mechanism compared to propofol, remimazolam is a new short-acting GABA-A receptor agonist. It is an ester-based benzodiazepine. This meta-analysis aims to clarify the efficacy and safety of remimazolam versus propofol for procedure sedation.. Electronic databases were searched for randomized controlled trials (RCTs) comparing efficacy or safety of remimazolam versus propofol. Meta-analysis were conducted using RStudio with "metafor" package with random-effects model.. A total of twelve RCTs were included in the meta-analysis. The pooled results demonstrated that patients with remimazolam for procedural sedation had lower risk of bradycardia (OR 0.28, 95% CI [0.14-0.57]), hypotension (OR 0.26, 95% CI [0.22-0.32]), and respiratory depression (OR 0.22, 95% CI [0.14-0.36]). There was no difference in the risk of developing postoperative nausea and vomiting (PONV) (OR 0.65, 95% CI [0.15-2.79]) and dizziness (OR 0.93, 95% CI [0.53-1.61]) between the remimazolam and propofol groups. Using remimazolam for procedural sedation is significantly associated with less injection pain compared to propofol (OR 0.06, 95% CI [0.03-0.13]). Regarding the sedation efficacy, there was no difference in sedation success rate or time to loss of consciousness, recover and discharge between the remimazolam and the propofol groups.. Based on our meta-analysis, patients receiving procedural sedation with remimazolam had lower risk of bradycardia, hypotension, respiratory depression and injection pain compared with propofol. On the other hand, there was no difference in sedation success rate, risk of PONV, dizziness, time to LOC, recovery and discharge between these two sedatives.. CRD42022362950.

Topics: Anesthesia; Benzodiazepines; Bradycardia; Conscious Sedation; Dizziness; Humans; Hypotension; Pain; Postoperative Nausea and Vomiting; Propofol; Randomized Controlled Trials as Topic; Respiratory Insufficiency

The aim of this systemic review and meta-analysis was to evaluate the efficacy and safety of remimazolam compared with propofol when used for procedural sedation and general anesthesia.. Data sources were PubMed, EMBASE, Web of Science, the Cochrane Central Register of Controlled Trials, and ClinicaTrials.gov, searched up to March 21, 2022. RCTs comparing remimazolam and propofol in patients undergoing procedural sedation or general anesthesia were searched. Pooled risk ratios (RRs) or standardized mean difference, 95% CIs, and P values were estimated for end points using the fixed- and random-effects statistical model. The trial sequential analysis was used for sensitivity analysis.. Ten studies with 1813 patients were included. Compared with propofol, remimazolam had lower success rate of sedation/general anesthesia (RR, 1.02; 95% CI: 1.01 to 1.03; P=0.004; N.=1402). However, remimazolam had lower incidence of hypoxia, hypotension, and injection pain than propofol. No difference in incidence of nausea and vomiting, time to awake and to discharge was found. Subgroup studies showed that remimazolam had lower success rate than propofol when used for procedural sedation, not general anesthesia. The trial sequential analysis adjusted confidence interval was 1.01 to 1.04 for success rate.. Remimazolam could be alternatively used in procedural sedation and general anesthesia. Additional research is needed to develop higher quality evidence on the use of remimazolam, especially in general anesthesia.

Topics: Anesthesia, General; Benzodiazepines; Humans; Hypnotics and Sedatives; Hypotension; Propofol

Remimazolam confers a lower risk of hypotension than propofol. However, no studies have compared the efficacy of remimazolam and propofol administered using target-controlled infusion (TCI). This study aimed to investigate hemodynamic effects of remimazolam and target-controlled propofol in middle-aged and elderly patients during the induction of anesthesia.. Forty adults aged 45-80 years with the American Society of Anesthesiologists Physical Status 1-2 were randomly assigned to remimazolam or propofol group (n = 20 each). Patients received either remimazolam (12 mg/kg/h) or propofol (3 μg/mL, TCI), along with remifentanil for inducing anesthesia. We recorded the blood pressure, heart rate (HR), and estimated continuous cardiac output (esCCO) using the pulse wave transit time. The primary outcome was the maximum change in mean arterial pressure (MAP) after induction. Secondary outcomes included changes in HR, cardiac output (CO), and stroke volume (SV).. MAP decreased after induction of anesthesia in both groups, without significant differences between the groups (- 41.1 [16.4] mmHg and - 42.8 [10.8] mmHg in remimazolam and propofol groups, respectively; mean difference: 1.7 [95% confidence interval: - 8.2 to 4.9]; p = 0.613). Furthermore, HR, CO, and SV decreased after induction in both groups, without significant differences between the groups. Remimazolam group had significantly shorter time until loss of consciousness than propofol group (1.7 [0.7] min and 3.5 [1.7] min, respectively; p < 0.001). However, MAP, HR, CO, and SV were not significantly different between the groups despite adjusting time until loss of consciousness as a covariate. Seven (35%) and 11 (55%) patients in the remimazolam and propofol groups, respectively, experienced hypotension (MAP < 65 mmHg over 2.5 min), without significant differences between the groups (p = 0.341).. Hemodynamics were not significantly different between remimazolam and target-controlled propofol groups during induction of anesthesia. Thus, not only the choice but also the dose and usage of anesthetics are important for hemodynamic stability while inducing anesthesia. Clinicians should monitor hypotension while inducing anesthesia with remimazolam as well as propofol.. UMIN-CTR (UMIN000045612).

Topics: Adult; Aged; Anesthesia, General; Anesthetics, Intravenous; Hemodynamics; Humans; Hypotension; Middle Aged; Piperidines; Propofol; Unconsciousness

In many countries, the combination of propofol and opioid is used as the preferred sedative regime during ERCP. However, the most serious risks of propofol sedation are oxygen deficiency and hypotension. Compared to midazolam, remimazolam has a faster onset and offset of hypnotic effect, as well as cardiorespiratory stability, and to achieve widespread acceptance for procedural sedation, remimazolam must replace propofol which is the most commonly used for procedural sedation. The objective of this study was to compare the safety and efficacy profiles of the remimazolam and propofol when combined with alfentanil for sedation during ERCP procedures.. A randomized, controlled, single-center trial.. The Endoscopic Centre of Tianjin Nankai Hospital, China.. 518 patients undergoing elective ERCP under deep sedation.. Patients scheduled for ERCP were randomly assigned to be sedated with either a combination of remimazolam-alfentanil or propofol-alfentanil.. The primary outcome was the prevalence of hypoxia, which was defined as SpO. A total of 518 patients underwent randomization. Of these, 250 were assigned to the remimazolam group and 255 to the propofol group. During ERCP, 9.6% of patients in the remimazolam group showed hypoxia, while in the propofol group, 15.7% showed hypoxia (p = 0.04). The need for airway maneuvering due to hypoxia was significantly greater in the propofol group (p = 0.04). Furthermore, patients sedated with remimazolam had a lower percentage of hypotension than patients sedated with propofol (p < 0.001). Patients receiving remimazolam sedation expressed higher satisfaction scores and were recommended the same sedation for the next ERCP. The procedure time in the remimazolam group was much longer than in the propofol group due to the complexity of the patient's disease, which resulted in a longer sedation time.. During elective ERCP, patients administered with remimazolam showed fewer respiratory depression events under deep sedation with hemodynamic advantages over propofol when administered in combination with alfentanil.

Topics: Alfentanil; Cholangiopancreatography, Endoscopic Retrograde; Conscious Sedation; Humans; Hypnotics and Sedatives; Hypotension; Hypoxia; Propofol

This study aimed to compare the cardiopulmonary safety of remimazolam and propofol in patients undergoing cervical conization.. This was a single-blind, parallel, randomized controlled study. A total of 204 patients scheduled for day surgery of cold knife cervical conization received either remimazolam-alfentanil anesthesia (remimazolam group) or propofol-alfentanil anesthesia (propofol group). The primary outcome was the incidence of intraoperative cardiopulmonary adverse events (a composite outcome of hypotension, bradycardia and hypoxemia). The occurrence of hypotension, bradycardia, hypoxemia and the degree of body movement were secondary outcomes, as well as the moment at which consciousness was lost, the interval between the end of anesthesia and the operating room's release of the patient, and the overall dosage of alfentanil administered during the procedure.. The incidence of intraoperative cardiopulmonary adverse events was 45 (44.1%) in the remimazolam group and 72 (70.6%) in the propofol group (absolute risk difference [95% CI], -26.47% [-39.55% to -13.39%]; odds ratio (OR) [95% CI], 0.43 [0.28 to 0.65];. In patients who underwent cold knife cervical conization, remimazolam-alfentanil anesthesia was associated with a reduced incidence of intraoperative cardiopulmonary adverse events compared with propofol-alfentanil anesthesia.

Topics: Alfentanil; Anesthetics, Intravenous; Benzodiazepines; Bradycardia; Conization; Humans; Hypotension; Hypoxia; Propofol; Single-Blind Method

Remimazolam tosilate (RT) is a novel short-acting GABA (A) receptor agonist that has a rapid recovery from procedural sedation and can be fully reversed by flumazenil. To date, there have been relatively few articles comparing RT and propofol for general anesthesia. This study aimed to assess the efficacy and safety of RT with or without flumazenil compared with propofol in general anesthesia for day surgery.. 115 patients scheduled for day surgery were randomized into three groups: RT (n = 39), RT + flumazenil (n = 38) and propofol (n = 38). The primary endpoints were anesthesia induction time and time until fully alert. Anesthesia success rate, bispectral index (BIS) values, injection pain, opioid and vasopressor dosages, postoperative recovery profiles and perioperative inflammatory and cognitive changes were assessed. Any adverse events were recorded.. Induction times were similar among the three groups (P = 0.437), but the median time until fully alert in patients treated with RT was longer than that of the propofol or RT + flumazenil groups (17.6 min vs. 12.3 min vs. 12.3 min, P < 0.001). The three groups had comparable postoperative recovery quality and inflammatory and cognitive state changes (P > 0.05). Smaller percentages of patients who received RT (26.3%) and RT + flumazenil (31.6%) developed hypotension during anesthesia maintenance compared with propofol (68.4%), and consequently less ephedrine (P < 0.001) and phenylephrine (P = 0.015) were needed in the RT group. Furthermore, serum triglyceride levels were lower (P < 0.001) and injection pain was much less frequent in the RT with or without flumazenil groups compared with the propofol group (5.3% vs. 0% vs. 18.4%).. RT permits rapid induction and comparable recovery profile compared with propofol in general anesthesia for day surgery, but has a prolonged recovery time without flumazenil. The safety profile of RT was superior to propofol in terms of hypotension and injection pain.. The study was registered at Chinese Clinical Trial Registry http://www.chictr.org.cn/ (Registration date: 19/7/2021; Trial ID: ChiCTR2100048904).

Topics: Ambulatory Surgical Procedures; Flumazenil; Humans; Hypotension; Pain; Propofol; Prospective Studies

Although the operation time of hysteroscopy is short, the incidence of postoperative nausea and vomiting is high. The aim of this study was to compare the incidence of postoperative nausea and vomiting in hysteroscopy when remimazolam is combined with remifentanil or alfentanil.. We conducted a randomized, controlled, double-blind trial. Patients undergoing hysteroscopy were recruited and randomly assigned to either the remimazolam-remifentanil (Group RR) or the remimazolam-alfentanil group (Group RA). All patients in the two groups were started with an induction dose of remimazolam besylate 0.2 mg/kg and then maintained with a dosage of 1.0 mg/kg/h. After induction with remimazolam besylate, in Group RR, remifentanil was infused using a target-controlled infusion system with a target concentration of 1.5 ng/ml and titrated throughout the procedure. In Group RA, infusion of alfentanil was started with an initial bolus dose of 20 µg/kg over 30 s and then maintained at an initial rate of 0.16 µg/kg/min. The primary observation outcome was the incidence rate of postoperative nausea and vomiting. The secondary observation outcomes were the time to awakening, the length of stay in the PACU, the total remimazolam dose and adverse effects, such as low SpO. A total of 204 patients were successfully included in this study. The incidence of postoperative nausea and vomiting in Group RR (2/102, 2.0%) was significantly lower than that in Group RA (12/102, 11.8%) (p < 0.05). There was no significant difference in the incidence of adverse events, such as low SpO. Remimazolam-remifentanil causes less postoperative nausea and vomiting than remimazolam-alfentanil in hysteroscopy.. Clinical trial registration number: ChiCTR2100044177. Full date of the first registration: 12/03/2021.

Topics: Alfentanil; Bradycardia; Female; Humans; Hypotension; Hysteroscopy; Postoperative Nausea and Vomiting; Pregnancy; Remifentanil

Certain routine medication could result in post-induction hypotension (PIH), such as angiotensin axis blockades, which are frequently administered as a first-line therapy against hypertension. Remimazolam is reportedly associated with lesser intraoperative hypotension than propofol. This study compared the overall incidence of PIH following remimazolam or propofol administration in patients managed by angiotensin axis blockades.. This single-blind, parallel-group, randomized control trial was conducted in a tertiary university hospital in South Korea. Patients undergoing surgery with general anesthesia were considered for enrollment if the inclusion criteria were met: administration of an angiotensin converting enzyme inhibitor or angiotensin receptor blocker, 19 to 65 years old, American Society of Anesthesiologists physical status classification ≤ III, and no involvement in other clinical trials. The primary outcome was the overall incidence of PIH, defined as a mean blood pressure (MBP) < 65 mmHg or decrease by ≥ 30% of the baseline MBP. The time points of measurement were baseline, just before the initial intubation attempt, and 1, 5, 10, and 15 min following intubation. The heart rate, systolic and diastolic blood pressures, and bispectral index were also recorded. Groups P and R included patients administered propofol and remimazolam, respectively, as an induction agent.. A total of 81 patients were analyzed, of the 82 randomized patients. PIH was less frequent in group R than group P (62.5% versus 82.9%; t value 4.27, P = 0.04, adjusted odds ratio = 0.32 [95% confidence interval 0.10-0.99]). The decrease in the MBP from baseline was 9.6 mmHg lesser in group R than in group P before the initial intubation attempt (95% confidence interval 3.3-15.9). A similar trend was observed for systolic and diastolic blood pressures. No severe adverse events were observed in either group.. Remimazolam results in less frequent PIH than propofol in patients undergoing routine administration of angiotensin axis blockades.. This trial was retrospectively registered on Clinical Research Information Service (CRIS), Republic of Korea (KCT0007488). Registration date: 30/06/2022.

Topics: Adult; Aged; Angiotensin-Converting Enzyme Inhibitors; Angiotensins; Benzodiazepines; Female; Humans; Hypotension; Intraoperative Care; Male; Middle Aged; Propofol; Single-Blind Method; Young Adult

The novel short-acting benzodiazepine remimazolam besylate acts rapidly and is used to induce easily controlled sedation. The aim of this study was to investigate the effects of remimazolam besylate combined with alfentanil in patients undergoing fiberoptic bronchoscopy with preserved spontaneous breathing.. 192 patients undergoing painless fiberoptic bronchoscopy were randomly assigned to either propofol (P group) or remimazolam besylate (R group); both groups also received alfentanil 10 µg/kg. The respiratory rate was recorded during the inspection. Mean arterial pressure (MAP), heart rate (HR), oxygen saturation (SpO2), Narcotrend values and Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scores were recorded after entry to the operating room (T0), 1 min (T1), 2 min (T2) and 3 min (T3) after anesthesia, immediately after the bronchoscope entered the vocal cords (T4), when the bronchoscope reached the carina (T5), the patient's eyes opened (T6), and 30 min postoperatively (T7). Secondary outcomes included intraoperative hypotension and body movement grading, etc. RESULTS: There was less respiratory depression during the inspection in the R group than in the P group (p < 0.01). The rate of hypotension during the examination was higher in the P group than in the R group (p < 0.01). Narcotrend values in the P group were less for the R group at the T1-T5 time points (p < 0.01). No difference in the number of body movements ≥ grade 3 was found between the two groups (p > 0.05).. Remimazolam besylate combined with alfentanil for painless fiberoptic bronchoscopy can better preserve the patient's spontaneous breathing and reduce the incidence of respiratory depression during the inspection than propofol.

Topics: Alfentanil; Benzodiazepines; Bronchoscopy; Humans; Hypnotics and Sedatives; Hypotension; Propofol; Prospective Studies; Respiratory Insufficiency

Hemodynamic variations during the induction of general anesthesia are more profound in hypertensive patients, and the risk of hypoperfusion-induced organ damage followed by hypotensive episodes is higher in hypertensive patients than in normotensive patients. Thus, we compared the effects of remimazolam and propofol on hemodynamics during general anesthesia induction in hypertensive patients.. Patients were randomly divided into the remimazolam (Group R, n = 48) and propofol (Group P, n = 48) groups: remimazolam was continued at 6 mg/kg/hour until the patient lost consciousness, followed by 1 mg/kg/hour until 5 minutes after tracheal intubation. Propofol was administered as a slow bolus of 1.5 to 2 mg/kg, followed by 3 to 6 mg/kg/hour 5 minutes after tracheal intubation. Hemodynamic parameters including mean blood pressure (MBP), systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, and incidence of hypotension were analyzed during the induction period, pre-induction (T1), immediately after loss of consciousness (T2), at 1 and 3 minutes after neuromuscular blockade (T3, T4), immediately after tracheal intubation (T5), and at 1, 3, and 5 minutes after tracheal intubation (T6, T7, T8).. The MBP, SBP, and DBP were significantly lower in the propofol group than in the remimazolam group (MBP: at T2, T3, T4, and T5; SBP: at T2, T3, and T4; DBP: at T5). HR was significantly lower in the propofol group at T3, T4, and T8. The incidence of hypotension was significantly higher in the propofol group than that in the remimazolam group. The incidence of bradycardia was comparable between the groups.. Remimazolam induction was more stable than propofol induction in preserving normal hemodynamics and was associated with a relatively lower incidence of hypotension. Remimazolam may be preferable to propofol for induction of anesthesia in patients with hypertension.

Topics: Anesthesia, General; Hemodynamics; Humans; Hypertension; Hypotension; Propofol

Hypotension is the most common adverse event under propofol-mediated sedation and is possible to cause varying degrees of damage to patients. Whereas remimazolam has a poorer sedative effect than propofol.. The aim of this study was to explore the advantages of the combination of remimazolam tosylate and propofol.. 304 patients were divided into the remimazolam tosylate group (RT group), the propofol group (P group), and the remimazolam tosylate plus propofol group(R+T group). The primary outcome was the incidence of hypotension. Secondary outcomes included the results of sedation and recovery. The safety results mainly include the incidence of Hypotension, adverse respiratory events, postoperative nausea and vomiting, hiccup, cough, body movement and bradycardia.. The incidence of hypotension was 56.7% in the P group, 12.6% in the RT group, and 31.3% in the R+P group, three groups of pairwise comparisons showed statistical differences, with P< 0.001. The incidence of body movement was significantly higher in the RT group (26.1%) than in the P group (10.3%) and the R+P group (12.5%), P = 0.004. The endoscopist satisfaction was higher in the P (3.87±0.44) and R+P (3.95±0.22)groups than in the RT(3.53±0.84) group. The incidence of adverse events, in descending order, was P group, RT group, and R+P group (93.8%vs.61.3%vs.42.7%).. Co-administration had fewer adverse events than propofol monotherapy, also had a better sedative effect and higher endoscopist satisfaction than remimazolam monotherapy.. Clinical trial registration number: NCT05429086.

Topics: Benzodiazepines; Endoscopy, Gastrointestinal; Humans; Hypnotics and Sedatives; Hypotension; Propofol

BACKGROUND This prospective, randomized, controlled study evaluated the efficacy and safety of remimazolam tosilate sedation with adjuvant sufentanil, relative to propofol, for Chinese patients with liver cirrhosis undergoing gastroscopy. MATERIAL AND METHODS Patients with liver cirrhosis (n=148) aged 18-65 years and undergoing gastroscopy were randomly and equally allocated to receive either 0.107 mg/kg remimazolam tosilate (remimazolam group) or 2 mg/kg propofol. Patients received intravenous sufentanil 0.15 μg/kg before the study drug. If necessary, an additional dose of propofol 20 mg was used and repeated. The primary outcome was the satisfaction rating (satisfactory, fair, or unsatisfactory) of the endoscopist with the sedation. Secondary outcomes were complications (respiratory depression, apnea, body movement, bradycardia, hypotension, nausea or vomiting, somnolence, dizziness, and fever) and patient satisfaction. RESULTS Compared with the propofol group, the remimazolam group required a longer time to sedation and a shorter time to emergence. The percentage of remimazolam sedations the endoscopist rated satisfactory (90.5%) was higher than that for propofol (77.0%; P=0.026). Patients given remimazolam experienced lower rates of respiratory depression, body movement, and hypotension (2.7, 8.1, 4.1%, respectively), than did the propofol group (17.6, 23.0, 14.9%; P=0.003, 0.013, 0.025). The 2 groups were comparable regarding the other secondary outcomes. CONCLUSIONS For Chinese patients with liver cirrhosis undergoing gastroscopy, remimazolam tosilate with adjuvant sufentanil provides a satisfactory level of sedation with a good safety profile.

Topics: Benzodiazepines; China; Gastroscopy; Humans; Hypnotics and Sedatives; Hypotension; Liver Cirrhosis; Propofol; Prospective Studies; Respiratory Insufficiency; Sufentanil

Remimazolam is an ultrashort-acting benzodiazepine that is potentially a practical option for procedural sedation in colonoscopy.. To test the hypothesis that remimazolam could provide a noninferior discharge time to propofol for ambulatory colonoscopy.. A prospective, randomised, double-blind, noninferiority clinical trial.. Ambulatory endoscopy centre.. A total of 132 adult participants undergoing ambulatory colonoscopy were enrolled.. Participants were randomly assigned in a 1 : 1 ratio to receive propofol or remimazolam for sedation.. The primary outcome was discharge time after a colonoscopy, assessed using the Modified Postanaesthetic Discharge Scoring System scale. Secondary outcomes included induction time, emergence time, the extent of recovery upon arrival in the postanaethesia care unit, fatigue, endoscopist and patient satisfaction and adverse events.. The median discharge time was 24 min in the remimazolam group versus 21 min in the propofol group, with a difference of 2 min [95% confidence interval (CI), 0 to 4 min], meeting the criteria for noninferiority. Injection pain occurred in 11 of 66 (17%) participants receiving remimazolam versus 32 of 66 (49%) participants receiving propofol ( P  < 0.001); hypotension occurrence was 20% versus 47%, ( P  < 0.001), respectively, and bradycardia 6% versus 20%, ( P  = 0.019), respectively. Compared with propofol, the patient satisfaction score was higher in the remimazolam group ( P  < 0.001).. For sedation in ambulatory colonoscopy, compared with propofol, remimazolam provides a noninferior discharge time. Furthermore, remimazolam is associated with less injection pain, lower risks of hypotension and bradycardia, and improved patient satisfaction.. Chinese Clinical Trial Registry, identifier: ChiCTR2100048678.

Topics: Adult; Benzodiazepines; Bradycardia; Colonoscopy; Humans; Hypnotics and Sedatives; Hypotension; Midazolam; Pain; Patient Discharge; Propofol; Prospective Studies

In geriatric patients, hypotension is often reported after general anesthesia induction using propofol. Remimazolam is a novel short-acting sedative. However, the incidence of hypotension after general anesthesia induction using remimazolam in geriatric patients remains unclear. This study aims to compare the incidence of hypotension associated with remimazolam and propofol in patients aged ≥80 years.. This single-center, double-blind, randomized, two-arm parallel group, standard treatment-controlled, interventional clinical trial will include 90 patients aged ≥80 years undergoing elective surgery under general anesthesia who will be randomized to receive remimazolam or propofol for induction. The primary outcome is the incidence of hypotension after general anesthesia induction, occurring between the start of drug administration and 3 min after intubation. We define hypotension as mean blood pressure <65 mmHg. The primary outcome will be analyzed using the full analysis set. The incidence of hypotension in the two groups will be compared using the Mantel-Haenszel χ2 test. Subgroup analysis of the primary outcome will be performed based on the Charlson comorbidity index, clinical frailty scale, hypertension in the ward, and age. Secondary outcomes will be analyzed using the Fisher's exact test, Student's t test, and Mann-Whitney U test, as appropriate. Logistic regression analysis will be performed to explore the factors associated with the incidence of hypotension after anesthesia induction.. Our trial will determine the efficacy of remimazolam in preventing hypotension and provide evidence on the usefulness of remimazolam for ensuring hemodynamic stability during general anesthesia induction in geriatric patients.. The study has been registered with UMIN Clinical Trials Registry (UMIN000042587), on June 30, 2021.

Topics: Aged; Anesthesia, General; Benzodiazepines; Double-Blind Method; Humans; Hypnotics and Sedatives; Hypotension; Propofol; Randomized Controlled Trials as Topic

Propofol is the most commonly used sedative in gastrointestinal endoscopic procedures, but is associated with cardiorespiratory suppression, particularly in elderly patients. Remimazolam is a new short-acting GABA(A) receptor agonist with minimal impact on cardiorespiratory suppression, and may be a viable alternative in elderly patients undergoing endoscopic procedures.. This multicenter, randomized controlled trial was conducted between September 2020 and September 2021. Elderly patients (65-85 years of age) scheduled to undergo upper gastrointestinal endoscopy were randomized in 1:1 ratio to receive remimazolam tosilate (300 mg/h) or propofol (3 g/h) in addition to 50-μg fentanyl, until the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) reached ≤1. MOAA/S was maintained at 0 or 1 throughout the procedure using 2.5 mg remimazolam or 0.5 mg/kg propofol boluses in the two groups, respectively. The primary outcome was the rate of hypotension (defined as systolic blood pressure at ≤90 mmHg or > 30% decline vs. the baseline). Bradycardia was defined as heart rate ≤50 per minute; respiratory depression was defined as respiratory rate <8 per minute and/or SpO. A total of 400 patients (161 men and 239 women; 70.4 ± 4.6 years of age) were enrolled (200 patients per group). Average body mass index was 22.2 ± 2.4 kg/m. Remimazolam was associated with a lower rate of hypotension in elderly patients undergoing upper gastrointestinal endoscopy under deep sedation/anaesthesia than propofol.

Topics: Aged; Anesthesia; Benzodiazepines; Bradycardia; Deep Sedation; Endoscopy, Gastrointestinal; Female; Humans; Hypnotics and Sedatives; Hypotension; Male; Propofol; Respiratory Insufficiency

Propofol is widely used for sedation of hysteroscopy. It can cause injection pain, respiratory depression, and hypotension. Remimazolam is a novel ultra-short-acting benzodiazepine. Clinical practice has found that the use of remimazolam alone often leads to body movement during hysteroscopy, which decreases the safety and comfort. Here this study is to investigate whether remimazolam combined with low-dose propofol can improve the sedation effect and safety of hysteroscopy.. In this prospective, randomized, parallel-controlled trial, women (18 to 60 years) undergoing hysteroscopy were randomly assigned to receive propofol (Group P), remimazolam tosylate (Group R), or remimazolam tosylate plus propofol (Group RP). Intraoperative sedation depth was kept at the bispectral index (BIS) value of 40-60. 6 μg/kg alfentanil was used for analgesic before sedation. Intraoperative low pulse oxygen saturation (SpO. From February to July 2022, 193 patients were recruited and randomly assigned to group P (n=64), group R (n=64), or group RP (n=65). There was no significant inter-group difference of the intraoperative BIS values. The incidence of low SpO. Remimazolam tosylate combined with low dose of propofol improved sedation and safety in hysteroscopy, and may be a more ideal sedative method for hysteroscopy.

Topics: Benzodiazepines; Dizziness; Female; Humans; Hypnotics and Sedatives; Hypotension; Hysteroscopy; Nausea; Pain; Pregnancy; Propofol; Prospective Studies; Vomiting

Patients with a history of cardiac disease are prone to develop cardiovascular adverse events such as hypotension, hypertension, and tachycardia during anesthesia induction. Therefore, hemodynamic stability is one of the most important concerns for induction of anesthesia in patients undergoing cardiac surgery. Remimazolam tosilate is a new, ultra-short-acting benzodiazepine agent, with the advantages of rapid onset, rapid offset, and minimal cardiorespiratory depression. We aim to compare the effect of remimazolam tosilate and etomidate on hemodynamics during anesthesia induction in patients undergoing valve replacement surgery.. The trial is a prospective, randomized, double-blinded, controlled, single-center trial to compare the effect of remimazolam tosilate and etomidate on hemodynamics in patients undergoing valve replacement surgery. One hundred seventeen patients undergoing selective valve replacement surgery between January 1, 2022, and December 31, 2023, will be enrolled and randomly allocated into one of three groups: low-dose remimazolam group (Group LR), high-dose remimazolam group (Group HR), or etomidate group (Group E). The primary outcome is hemodynamic fluctuations during anesthesia induction (the difference between mean arterial pressure [MAP] to baseline, ▴MAP; and the difference between maximum or minimum heart rate [HR] and baseline, ▴HR). Secondary outcomes include the incidence of adverse cardiovascular events (hypotension, severe bradycardia, hypertension, tachycardia, and arrhythmia), the cumulative doses of vasoactive drugs used per patient, incidence and degree of injection pain and myoclonus, blood glucose values, and vital signs at different time points.. This research will determine the effectiveness and safety of remimazolam tosilate induction on hemodynamics in patients undergoing valve replacement surgery.. www.chictr.org .cn identifier ChiCTR2100052535 . Registered on 17th Dec 2021, http://www.chictr.org.cn/ ).

Topics: Anesthesia, General; Anesthetics, Intravenous; Benzodiazepines; Etomidate; Humans; Hypertension; Hypotension; Prospective Studies; Randomized Controlled Trials as Topic

The stability of hemodynamics during anesthesia induction in patients undergoing valve replacement surgery is particularly important. Remimazolam is a new type of benzodiazepine drug, with supposed advantages of rapid induction, rapid recovery, stable hemodynamics, and mild respiratory inhibition.. To evaluate the effect of remimazolam anesthesia induction on hemodynamics in patients undergoing valve replacement surgery.. This randomized, double-blind, controlled trial enrolled consecutive patients undergoing mitral valve replacement (MVR)/aortic valve replacement (AVR)/double-valve replacement (DVR) surgery on cardiopulmonary bypass (CPB). The study was conducted according to the Consolidated Standards of Reporting Trials statement. Participants were randomly assigned to receive either remimazolam or propofol induction of 30 patients each. All patients, data collectors, and data analyzers were blinded to the group allocation. The primary outcomes were the fluctuations in hemodynamic parameters (the difference of maximum or minimum heart rate to baseline, ▲HR, the difference of maximum or minimum mean arterial pressure to baseline, ▲MAP), the occurrence of cardiovascular events (hypotension, severe bradycardia), and the cumulative norepinephrine doses used per patient, averaged per group during induction. The secondary outcomes were hemodynamic parameters (heart rate, HR, mean arterial pressure, MAP, bispectral index, BIS, plasma lactic acid, Lac, and blood glucose, Glu values).. A total of 60 patients with heart valve replacement were included in the final analysis, with 30 patients in each group. The ▲MAP was significantly lower in the remimazolam group than in the propofol group during induction (p < .05). The incidences of hypotension and the cumulative norepinephrine doses used per patient, averaged per group during induction were significantly lower in the remimazolam group than in the propofol group (p < .05).. Remimazolam may be safe and effective for induction and may as an alternative to propofol during anesthesia induction in patients undergoing valve replacement surgery.

Topics: Adult; Aged; Anesthetics, Intravenous; Aortic Valve; Arterial Pressure; Benzodiazepines; Bradycardia; Cardiopulmonary Bypass; Double-Blind Method; Female; Heart Rate; Heart Valve Prosthesis Implantation; Hemodynamics; Humans; Hypotension; Intraoperative Complications; Male; Middle Aged; Mitral Valve; Norepinephrine; Propofol; Sympathomimetics