Remimazolam-Flumazenil Versus Sevoflurane for Hysteroscopic Day Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Remimazolam: Remimazolam will be administered at 12 mg/kg/h for induction of anesthesia until loss of consciousness, followed by maintenance at 1-2 mg/kg/h until the end of surgery.

Flumazenil: Flumazenil 0.5 mg will be administered intravenously at the end of surgery to reverse remimazolam-induced sedation. Additional doses of 0.2 mg may be administered if necessary, up to a maximum total dose of 1.0 mg.

Sevoflurane: Sevoflurane will be administered at 1.5-3.5 vol% for maintenance of anesthesia following propofol induction. At the end of surgery, sevoflurane administration will be discontinued and washout will be facilitated using fresh gas flow of 6 L/min.

propofol: Propofol 2 mg/kg will be administered intravenously for induction of anesthesia before initiation of sevoflurane maintenance.

Study summary

This prospective, single-center, randomized controlled trial aims to compare remimazolam anesthesia with planned flumazenil reversal and sevoflurane-based balanced anesthesia in adult women undergoing ambulatory hysteroscopic surgery.

Participants will be randomly assigned in a 1:1 ratio to receive either remimazolam for induction and maintenance followed by flumazenil reversal or propofol induction followed by sevoflurane-based balanced anesthesia. The primary outcome is anesthesia-controlled time, defined as the sum of induction time and emergence time. Secondary outcomes include recovery profiles, postoperative symptoms, quality of recovery, hemodynamic stability, and the incidence of re-sedation. The study will evaluate whether a remimazolam-flumazenil strategy can improve operating room efficiency while maintaining recovery quality and safety comparable to conventional sevoflurane-based anesthesia in the ambulatory surgery setting.

Eligibility

Primary outcome measure(s)

• Anesthesia-Controlled Time — From initiation of anesthesia to removal of the supraglottic airway device during emergence from anesthesia, assessed up to 120 minutes.
  Anesthesia-controlled time is defined as the sum of induction time and emergence time. Induction time is measured from initiation of the anesthetic agent to successful placement of the supraglottic airway device. Emergence time is measured from discontinuation of the primary anesthetic agent to removal of the supraglottic airway device.

Trial sites (1)

Other trials for the same condition