# Efficacy and Recovery of Remimazolam Versus Midazolam in Sedated Colonoscopy: A Multicenter Randomized Controlled Trial in Japan

## TL;DR

This study compares remimazolam and midazolam for sedation during colonoscopy in Japan, finding that remimazolam allows faster recovery with similar sedation effectiveness.

## Contribution

The study demonstrates remimazolam's superior recovery time compared to midazolam in colonoscopy sedation without compromising sedation quality.

## Key findings

- 100% of remimazolam patients could ambulate 5 minutes post-procedure, compared to 19.1% with midazolam.
- Remimazolam patients regained full alertness significantly faster than midazolam patients.
- Both drugs achieved successful pre-procedure sedation in all patients.

## Abstract

Sedation during colonoscopy is becoming increasingly important. Remimazolam, an ultra‐short‐acting benzodiazepine, has a shorter pharmacokinetic half‐life than that of midazolam. This study examined whether remimazolam provides superior sedation during colonoscopy in Japanese patients.

This prospective, multicenter, randomized, single‐blind, controlled trial included adults (18–80 years) scheduled for sedated colonoscopy. Participants were randomized to the remimazolam and midazolam groups. The primary outcome was the proportion of ambulatory patients 5 min after colonoscopy. Secondary outcomes were successful pre‐procedure sedation (Modified Observer's Assessment of Alertness/Sedation [MOAA/S] ≤ 4), recovery time, total sedative dose, and adverse events.

Forty patients were enrolled and analyzed (remimazolam, n = 19; midazolam, n = 21). At 5 min post‐colonoscopy, ambulation was achieved in 100% (19/19) of remimazolam patients and 19.1% (4/21) of midazolam patients (p < 0.0001). The median time [interquartile range (IQR)] from procedure end to full alertness (MOAA/S = 5) was 0 [0–0] min for remimazolam and 10 [5–20] min for midazolam (p < 0.0001). The median time [IQR] from procedure end to independent ambulation was 0 [0–5] min for remimazolam and 20 [10–30] min for midazolam (p < 0.001). Pre‐procedure sedation was successful (MOAA/S ≤ 4) in 100% of both groups. The median amount [IQR] of total sedative dose was 5 [4–6] mg for remimazolam and 3 [3] mg for midazolam. Hypoxemia occurred in 5.3% and 9.5% of patients in the remimazolam and midazolam groups, respectively.

Compared with midazolam, remimazolam resulted in significantly faster recovery after colonoscopy in Japanese patients, with comparable achievement of target sedation and a low incidence of hypoxemia.

Trial number: jRCTs071240062