Remimazolam-Flumazenil Versus Sevoflurane for Hysteroscopic Day Surgery
Starting soon · Phase 4
Conditions studied: Hysteroscopy, Ambulatory Surgery, General Anesthesia
In brief
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.
Key facts
- Study ID
- NCT07663877
- Run by
- Chung-Ang University Gwangmyeong Hospital
- People needed
- 124
- Starts
- 2026-06-01
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-06-23
Who can join
Age: 20 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
- Epilepsy or other significant neurologic disorders.
- Pregnancy or breastfeeding.
- Body mass index (BMI) ≥35 kg/m².
- Severe obstructive sleep apnea.
- Uncontrolled serious systemic disease that may preclude ambulatory surgery.
- Refusal or inability to provide informed consent.
Where it is running
- Chung-Ang University Gwangmyeong Hospital — Gwangmyeong, Gyeonggi-do, South Korea
Full record on ClinicalTrials.gov
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