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NOT YET RECRUITING
NCT07663877
PHASE4

Remimazolam-Flumazenil Versus Sevoflurane for Hysteroscopic Day Surgery

Sponsor: Chung-Ang University Gwangmyeong Hospital

View on ClinicalTrials.gov

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.

Official title: Remimazolam With Planned Flumazenil Reversal Versus Sevoflurane-based Balanced Anesthesia for Hysteroscopic Day Surgery: A Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2026-06

Completion Date

2028-06

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

propofol

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

Locations (1)

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Gyeonggi-do, South Korea