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. 2021 Jun 11;9(1):24514. doi: 10.52965/001c.24514

Table 1. Remimazolam’s Clinical Safety and Efficacy.

Table 1: Clinical Safety and Efficacy 
Author (Year)  Groups Studied and Intervention Results and Findings Conclusions
Sheng et al. (2019) Healthy Chinese patients Sedation function was observed at the dose of 0.05 mg/kg remimazolam. Doses of >0.075 exerted a peak sedation effect within 1-2 min after injection. For general anesthesia, an induction dosage of 0.2 mg/kg/min and a maintenance dosage of 1mg/kg/h achieved satisfactory efficacy effect. Remimazolam was safe and well-tolerated in healthy Chinese participants.
Antonik et al. (2012) Ten cohorts of health subjects randomized to receive a 1-minute IV infusion of remimazolam, midazolam, or placebo Pharmacokinetic behavior of remimazolam linear and its systemic clearance was approximately three times of midazolam. Administration of 0.05 mg/kg and higher doses of remimazolam achieved a rapid onset and dose-dependent sedation. Remimazolam provided rapid onset and offset sedation with minimal adverse events. Further studies on the use of remimazolam for sedation can be conducted. 
Doi et al. (2020) Surgical patients randomized to remimazolam at 6 or 12 mg/kg/h infusion  Remimazolam had a longer time to LOC and longer time to extubate but overall was non-inferior compared to propofol Remimazolam was well tolerated and non-inferior to propofol for general anesthesia
Worthington et al. (2013) Healthy volunteers receiving remimazolam for sedation during colonoscopy  Over 70% of subjects had successful sedation with remimazolam with a median recovery time of <10 minutes after the procedure Remimazolam has success rates comparable to other drugs for induction during colonoscopy. Further studies with the use of remimazolam in patients receiving colonoscopy or other GI procedures can be conducted
Pambianco et al.  (2015) 162 patients aged 18-70 scheduled to receive a routine colonoscopy Single-dose of remimazolam provided >92% success rate for the remimazolam group compared to 75% for the midazolam group Remimazolam provided high levels of success rate for induction during colonoscopy compared to midazolam. Further studies assessing the use of remimazolam for patients undergoing colonoscopy or other GI procedures can be conducted
Borkett et al. (2015) Patients scheduled to undergo a diagnostic upper gastrointestinal endoscopy randomized to receive 1 of 3 doses of remimazolam or midazolam The onset of sedation in remimazolam dose group was 1.5 - 2.5 minutes compared to 5 minutes for the midazolam group A single administration of remimazolam with a dosage of 0.10-0.20 mg/kg was able to induce patients undergoing diagnostic upper gastrointestinal endoscopy with a similar safety profile as midazolam
Chen et al. (2020) 384 patients undergoing colonoscopy randomized to receive remimazolam or propofol Remimazolam was noted to be non-inferior to propofol with similar success rates and induction time of sedation Remimazolam is non-inferior in sedation efficacy while safer than propofol in patients undergoing colonoscopy
Chen et al. (2020) 384 patients undergoing upper endoscopy randomized to receive remimazolam or propofol Remimazolam was noted to be non-inferior than propofol, with a shorter time to be fully alert and lower incidences of hypotension and respiratory depression Remimazolam is non-inferior to propofol and allows for faster recovery from sedation. In addition, it appears to be superior to propofol with adverse events
Pastis et al. (2018) Patients undergoing flexible bronchoscopy receiving either remimazolam or midazolam The success rate in the remimazolam group was 80.6% compared to 32.9% in the midazolam group. In addition, time to full alertness in the remimazolam group was shorter compared to midazolam.  Remimazolam was effective and safe for moderate sedation during bronchoscopy and demonstrated a shorter onset of action and faster neuropsychiatric recovery than midazolam.