Remimazolam-Flumazenil Versus Sevoflurane for Hysteroscopic Day Surgery (NCT07663877) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Remimazolam-Flumazenil Versus Sevoflurane for Hysteroscopic Day Surgery
South Korea124 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
20 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Anesthesia-Controlled Time
Timeframe: From initiation of anesthesia to removal of the supraglottic airway device during emergence from anesthesia, assessed up to 120 minutes.