Remimazolam-Flumazenil Versus Sevoflurane for Hysteroscopic Day Surgery

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age20+
SponsorChung-Ang University Gwangmyeong Hospital

About this trial

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 criteria

Qualifiers

Female patients aged 20 years or older.

Scheduled to undergo ambulatory hysteroscopic surgery under general anesthesia.

Able to provide written informed consent.

American Society of Anesthesiologists (ASA) physical status I-III.

Disqualifiers

Known hypersensitivity to benzodiazepines, remimazolam, or flumazenil.

Chronic use of benzodiazepines or opioids.

Severe hepatic dysfunction (Child-Pugh class B or C).

Severe renal dysfunction (estimated glomerular filtration rate <30 mL/min/1.73 m²).

Trial design

Treatments tested in this trial

  • Remimazolam
  • Flumazenil
  • Sevoflurane
  • propofol

Treatment groups

124 Participants
are divided into 2 treatment groups