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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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07663877). StuddyBuddy aggregates publicly available trial information.