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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Remimazolam
DrugRemimazolam will be administered at 12 mg/kg/h for induction of anesthesia until loss of consciousness, followed by maintenance at 1-2 mg/kg/h until the end of surgery.
Flumazenil
DrugFlumazenil 0.5 mg will be administered intravenously at the end of surgery to reverse remimazolam-induced sedation. Additional doses of 0.2 mg may be administered if necessary, up to a maximum total dose of 1.0 mg.
Sevoflurane
DrugSevoflurane will be administered at 1.5-3.5 vol% for maintenance of anesthesia following propofol induction. At the end of surgery, sevoflurane administration will be discontinued and washout will be facilitated using fresh gas flow of 6 L/min.
propofol
DrugPropofol 2 mg/kg will be administered intravenously for induction of anesthesia before initiation of sevoflurane maintenance.
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: remimazolam-fumazeil groupExperimental treatment 2 interventions
Group B: sevoflurane groupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Anesthesia-Controlled Time
Anesthesia-controlled time is defined as the sum of induction time and emergence time. Induction time is measured from initiation of the anesthetic agent to successful placement of the supraglottic airway device. Emergence time is measured from discontinuation of the primary anesthetic agent to removal of the supraglottic airway device.
Time frame
From initiation of anesthesia to removal of the supraglottic airway device during emergence from anesthesia, assessed up to 120 minutes.Secondary outcomes
1
Time to Aldrete Score ≥9
Time required to achieve an Aldrete score of at least 9 following admission to the post-anesthesia care unit (PACU).
Time frame
Up to 30 minutes after PACU admission2
Length of Stay in PACU
Duration of stay in the post-anesthesia care unit.
Time frame
From admission to the post-anesthesia care unit until discharge from the post-anesthesia care unit, assessed up to 2 hours.3
Postoperative Symptoms During the Acute Recovery Phase
Postoperative symptoms during the acute recovery phase will be assessed in the post-anesthesia care unit using 11-point Numeric Rating Scales. Symptoms include nausea, sore throat, surgical pain, shivering, and dizziness, each scored from 0 to 10, with 0 indicating no symptom and 10 indicating the worst imaginable symptom. The occurrence of vomiting will also be recorded.
Time frame
During PACU stay, up to 30 minutes after PACU admission4
Quality of Recovery-15 (QoR-15) Score
Quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire. The QoR-15 is a validated patient-reported outcome measure ranging from 0 to 150 points, with higher scores indicating better postoperative recovery.
Time frame
24 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov
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