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Remimazolam-Flumazenil Versus Sevoflurane for Hysteroscopic Day Surgery

NCT07663877 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2026-06-23

No results posted yet for this 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.

Conditions

  • Hysteroscopy
  • Ambulatory Surgery
  • General Anesthesia

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.

Sponsors & Collaborators

  • Chung-Ang University Gwangmyeong Hospital

    lead OTHER

Principal Investigators

  • Jiwon Han · Chung-Ang University Gwangmyeong Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07663877 on ClinicalTrials.gov