remimazolam and Bradycardia

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

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

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

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

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

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