Remimazolam versus sevoflurane for maintenance of anesthesia and postoperative nausea and vomiting in laparoscopic gynecologic oncology surgery: a randomized controlled trial
TL;DR
Remimazolam-based anesthesia was associated with a lower incidence of PONV compared with sevoflurane in patients undergoing laparoscopic gynecologic oncology surgery, and the observed reduction was slightly smaller than the effect size predefined during sample size estimation.
Abstract
Postoperative nausea and vomiting (PONV) remains a frequent complication following laparoscopic gynecologic surgery, particularly in female patients with multiple established risk factors receiving volatile anesthetics. Remimazolam, a short-acting benzodiazepine, is an alternative intravenous anesthetic, but its effect on PONV compared with sevoflurane remains unclear. In this single-center, prospective randomized controlled trial, 116 patients were enrolled and 113 were included in the final analysis (sevoflurane n = 56, remimazolam n = 57). Patients were randomly assigned to receive either sevoflurane-based or remimazolam-based maintenance of anesthesia. The primary outcome was the incidence of PONV within 24 h after surgery. Exploratory analyses were performed to evaluate the associations between PONV and perioperative factors, including intraoperative hemodynamic variables, fluid administration, and opioid consumption. The incidence of PONV within 24 h was lower in the remimazolam group than in the sevoflurane group (21.1% vs. 44.6%, P = 0.013). Remimazolam was associated with reduced PONV incidence compared with sevoflurane. Although remimazolam was associated with higher intraoperative mean arterial pressure (MAP), exploratory analyses did not identify a significant association between intraoperative MAP and PONV. The observed absolute reduction in PONV incidence was 23.6%, which was slightly lower than the predefined effect size used for sample size estimation. Remimazolam-based anesthesia was associated with a lower incidence of PONV compared with sevoflurane in patients undergoing laparoscopic gynecologic oncology surgery. Although statistically significant, the observed reduction was slightly smaller than the effect size predefined during sample size estimation, and its clinical relevance requires further evaluation. ChiCTR2600128362. (Retrospectively registered). The initial registration date was 07/17/2026.