Remimazolam versus propofol for sedation in gastrointestinal endoscopic procedures: a systematic review and meta-analysis

Aims This systematic review and meta-analysis aimed to compare efficacy-, safety-, and satisfaction-related outcomes between remimazolam, a novel benzodiazepine, and propofol, both combined with fentanyl congeners (FC), for sedation of adults undergoing gastrointestinal (GI) endoscopic procedures.

Methods MEDLINE, Embase, and Cochrane databases were searched for randomized controlled trials (RCTs) comparing remimazolam-FC with propofol-FC for sedation of adults undergoing GI endoscopy and reporting at least one of the outcomes of interest. The primary outcome was sedation success. Secondary outcomes were time variables (induction time, total sedation time, time to full alertness, procedure duration, and time to anesthesia discharge), adverse events (respiratory depression, hypotension, hypotension requiring treatment, bradycardia, and nausea/vomiting), and patient and endoscopist satisfaction. The risk ratio (RR) and mean difference (MD) were applied with their 95% confidence intervals (95% CIs) for dichotomous and continuous outcomes, respectively, using a random-effects model. We performed sensitivity analyses if I²≥50% and subgroup assessments by age range (elderly [≥65 years] vs. young [<65 years]) for all outcomes. We deemed p<0.05 statistically significant. R statistical software was used for statistical analyses. [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12]

Results Twelve RCTs (4,103 patients) were included. Five studies (37.6% of patients) evaluated only patients aged≥65 years. 27.0% of patients underwent colonoscopy, 43.8% gastroscopy, 16.9% colonoscopy and/or gastroscopy, and 12.3% endoscopic retrograde cholangiopancreatography. Remimazolam was associated with a significantly lower sedation success rate (RR 0.989; 95% CI 0.979-0.998; p=0.03) and a slightly longer induction time (MD 9.52 seconds; 95% CI 3.76-15.29; p<0.01), while there were no significant difference between the drugs in other time-related outcomes. Remimazolam use showed a significantly lower risk of respiratory depression (RR 0.45; 95% CI 0.34-0.59; p<0.01), hypotension (RR 0.46; 95% CI 0.38-0.55; p<0.01), hypotension requiring treatment (RR 0.35; 95% CI 0.18-0.67; p<0.01), and bradycardia (RR 0.45; 95% CI 0.31-0.65; p<0.01). Patient satisfaction was greater with remimazolam (MD 0.82; 95% CI 0.50-1.14; p=0.01), whereas there was no difference in endoscopist satisfaction (MD -0.01; 95% CI: -0.07-0.06; p=0.26). The subgroup analysis by age range showed that there were statistically differences between the subgroups only in terms of induction time – where propofol provided a shorter time only in the young –, as well as respiratory depression and hypotension – where the young showed a slightly greater benefit with remimazolam compared to the elderly subgroup.

Conclusions Compared to propofol, remimazolam demonstrated clinically similar efficacy, better safety profile, and greater patient satisfaction regarding the procedure for sedation of adults undergoing GI endoscopy, with equivalent results in young and elderly populations.

Publication History

Article published online:
15 April 2024

• References

• 1 Guo J, Qian Y, Zhang X, Han S, Shi Q, Xu J.. Remimazolam tosilate compared with propofol for gastrointestinal endoscopy in elderly patients: a prospective, randomized and controlled study. BioMed Central anesthesiology 2022; 22: 180
• 2 Yao Y, Guan J, Liu L, Fu B, Chen L, Zheng X.. Discharge readiness after remimazolam versus propofol for colonoscopy: A randomised, double-blind trial. European journal of anaesthesiology 2022; 39: 911-7
• 3 Shi W, Cheng Y, He H. et al. Efficacy and Safety of the Remimazolam-Alfentanil Combination for Sedation During Gastroscopy: A Randomized, Double-blind, Single-center Controlled Trial. Clinical therapeutics 2022; 44: 1506-18
• 4 Dong SA, Guo Y, Liu SS. et al. A randomized, controlled clinical trial comparing remimazolam to propofol when combined with alfentanil for sedation during ERCP procedures. Journal of clinical anesthesia 2023; 86: 111077
• 5 Liu F, Cheng X, Wang Y. et al. Effect of remimazolam tosilate on the incidence of hypoxemia in elderly patients undergoing gastrointestinal endoscopy: A bi-center, prospective, randomized controlled study. Frontiers in pharmacology 2023; 14: 1131391
• 6 Xin Y, Chu T, Wang J, Xu A.. Sedative effect of remimazolam combined with alfentanil in colonoscopic polypectomy: a prospective, randomized, controlled clinical trial. BioMed Central anesthesiology 2022; 22: 262
• 7 Hu B, Jiang K, Shi W. et al. Effect of Remimazolam Tosilate on Respiratory Depression in Elderly Patients Undergoing Gastroscopy: A Multicentered, Prospective, and Randomized Study. Drug design, development and therapy 2022; 16: 4151-9
• 8 Chen SH, Yuan TM, Zhang J. et al. Remimazolam tosilate in upper gastrointestinal endoscopy: A multicenter, randomized, non-inferiority, phase III trial. Journal of gastroenterology and hepatology 2021; 36: 474-81
• 9 Chen S, Wang J, Xu X. et al. The efficacy and safety of remimazolam tosylate versus propofol in patients undergoing colonoscopy: a multicentered, randomized, positive-controlled, phase III clinical trial. American journal of translational research 2020; 12: 4594-603
• 10 Xu C, He L, Ren J. et al. Efficacy and Safety of Remimazolam Besylate Combined with Alfentanil in Painless Gastroscopy: A Randomized, Single-Blind, Parallel Controlled Study. Contrast media & molecular imaging 2022; 2022: 7102293
• 11 Wang X, Hu X, Bai N. et al. Safety and efficacy of remimazolam besylate in patients undergoing colonoscopy: A multicentre, single-blind, randomized, controlled, phase III trial. Frontiers in pharmacology 2022; 13: 900723
• 12 Lu K, Wei S, Ling W. et al. Remimazolam versus propofol for deep sedation/anaesthesia in upper gastrointestinal endoscopy in elderly patients: A multicenter, randomized controlled trial. Journal of clinical pharmacy and therapeutics 2022; 47: 2230-6