Comparing Cognitive Recovery of Remimazolam versus Propofol in Elderly Patients Undergoing Colonoscopy: A Randomized Controlled Trial

Clin Interv Aging. 2024 Dec 16:19:2133-2143. doi: 10.2147/CIA.S490330. eCollection 2024.

Abstract

Background: Remimazolam, a novel ultra-short-acting benzodiazepine, shows promise for procedural sedation. This study compared the cognitive recovery of remimazolam versus propofol in elderly patients undergoing colonoscopy.

Patients and methods: In this prospective, randomized, double-blind, controlled trial, 228 patients aged ≥ 65 years undergoing outpatient colonoscopies were recruited. Patients received intravenous sufentanil 0.05 μg/kg, followed by either remimazolam 0.2 mg/kg or propofol 1 mg/kg for sedation induction. The assigned study drug (remimazolam 0.1 mg/kg or propofol 0.5 mg/kg) was titrated to maintain a Modified Observer's Assessment of Alertness/Sedation scale score < 3 during the procedure. The primary outcome was the incidence of cognitive recovery, assessed using the Postoperative Quality of Recovery Scale (PostopQRS) cognitive domain on postoperative day 3. Secondary outcomes included overall and other PostopQRS domains recovery, time to discharge, patient satisfaction, and adverse events.

Results: Cognitive recovery on day 3 was similar between remimazolam (84.2%) and propofol (85.1%) groups (risk ratio = 0.99; 95% CI: 0.89-1.11; p = 0.854). No significant differences were observed in overall recovery, other domains, or discharge time. Remimazolam patients reported higher satisfaction (p = 0.001) and experienced lower incidences of hypotension (21.9% vs 53.5%; p < 0.001), hypoxemia (6.1% vs 16.7%; p = 0.024), and injection site pain (15.8% vs 41.2%; p < 0.001) compared to propofol.

Conclusion: In elderly patients undergoing colonoscopy, remimazolam demonstrated comparable cognitive recovery to propofol, with higher patient satisfaction and a more favorable safety profile. Remimazolam may be the preferred alternative to propofol for procedural sedation in this vulnerable population.

Trial registration: The Chinese Clinical Trial Registry, ChiCTR2200066689.

Keywords: cognitive recovery; colonoscopy; elderly patients; postoperative quality of recovery; propofol; remimazolam.

Publication types

  • Randomized Controlled Trial
  • Comparative Study
  • Case Reports
  • Clinical Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anesthesia Recovery Period
  • Benzodiazepines* / administration & dosage
  • Benzodiazepines* / therapeutic use
  • Cognition* / drug effects
  • Colonoscopy*
  • Double-Blind Method
  • Female
  • Humans
  • Hypnotics and Sedatives* / administration & dosage
  • Male
  • Patient Satisfaction
  • Propofol* / administration & dosage
  • Prospective Studies

Substances

  • Propofol
  • remimazolam
  • Hypnotics and Sedatives
  • Benzodiazepines

Grants and funding

This study was funded by the Science and Technology Program of Haicang District of Xiamen, China (grant number 350205Z20232004), the Natural Science Foundation of Xiamen, China (grant number 3502Z202374068), National Natural Science Foundation Basic Research Enhancement Program Special Project (grant number JCZX202404), Fujian Strait Medical and Health Exchange Association Precision Anesthesia Research Project (grant number 2024HYHMZ04), Fujian Provincial Health Technology Project (grant number 2022CXA007), Fujian Provincial Natural Science Foundation (grant number 2022J01847), and Joint Funds for the Innovation of Science and Technology, Fujian province (grant number 2023Y9275). The funders had no role in study design, data collection and analysis, publication decisions, or manuscript preparation.