← Back to all trials
Not Yet Recruiting
NCT07663877
Remimazolam-Flumazenil Versus Sevoflurane for Hysteroscopic Day Surgery
Conditions: Hysteroscopy, Ambulatory Surgery, General Anesthesia
Sex: Female
Ages: 20 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 124
Sponsor: Chung-Ang University Gwangmyeong Hospital
Location: Chung-Ang University Gwangmyeong Hospital Gwangmyeong Gyeonggi-do
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07663877). StuddyBuddy aggregates publicly available trial information.