Remimazolam-Flumazenil Versus Sevoflurane for Hysteroscopic Day Surgery

NCT07663877 | Not Yet Recruiting Phase 4

• 1 other identifier: 2604-323-074
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hysteroscopy; Ambulatory Surgery; General Anesthesia

Keywords

remimazolam; flumazenil; sevoflurane; ambulatory surgery; day surgery; hysteroscopy; general anesthesia; recovery profile; anesthesia controlled time

Outcome Measures

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.

  From initiation of anesthesia to removal of the supraglottic airway device during emergence from anesthesia, assessed up to 120 minutes.

Secondary Outcomes (5)

• Time to Aldrete Score ≥9

  Up to 30 minutes after PACU admission

• Length of Stay in PACU

  From admission to the post-anesthesia care unit until discharge from the post-anesthesia care unit, assessed up to 2 hours.

• Postoperative Symptoms During the Acute Recovery Phase

  During PACU stay, up to 30 minutes after PACU admission

• Quality of Recovery-15 (QoR-15) Score

  24 hours after surgery

• Incidence of Re-sedation

  From PACU admission through discharge from the ambulatory surgery center, assessed up to 8 hours after surgery.

Study Arms (2)

remimazolam-fumazeil group

EXPERIMENTAL

Participants will receive remimazolam for induction and maintenance of general anesthesia. At the end of surgery, flumazenil will be administered to facilitate rapid emergence from anesthesia. Standardized perioperative management, including fentanyl, rocuronium, supraglottic airway management, and postoperative monitoring, will be applied.

Drug: Remimazolam; Drug: Flumazenil

sevoflurane group

ACTIVE COMPARATOR

Participants will receive propofol for induction of general anesthesia followed by maintenance with sevoflurane-based balanced anesthesia. Standardized perioperative management will be applied similarly to the experimental group.

Drug: Sevoflurane; Drug: propofol

Interventions

Remimazolam DRUG

Remimazolam 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.

remimazolam-fumazeil group

Flumazenil DRUG

Flumazenil 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.

remimazolam-fumazeil group

Sevoflurane DRUG

Sevoflurane 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.

sevoflurane group

propofol DRUG

Propofol 2 mg/kg will be administered intravenously for induction of anesthesia before initiation of sevoflurane maintenance.

sevoflurane group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Chung-Ang University Gwangmyeong Hospital: lead

Study Sites (1)

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Gyeonggi-do, 14353, South Korea

Location

Related Publications (3)

• Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

  PMID: 23411725 RESULT

• Kilpatrick GJ, McIntyre MS, Cox RF, Stafford JA, Pacofsky GJ, Lovell GG, Wiard RP, Feldman PL, Collins H, Waszczak BL, Tilbrook GS. CNS 7056: a novel ultra-short-acting Benzodiazepine. Anesthesiology. 2007 Jul;107(1):60-6. doi: 10.1097/01.anes.0000267503.85085.c0.

  PMID: 17585216 RESULT

• Doi M, Morita K, Takeda J, Sakamoto A, Yamakage M, Suzuki T. Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase IIb/III trial. J Anesth. 2020 Aug;34(4):543-553. doi: 10.1007/s00540-020-02788-6. Epub 2020 May 16.

  PMID: 32417976 RESULT

MeSH Terms

Interventions

remimazolam; Flumazenil; Sevoflurane; Propofol

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Jiwon Han

  Chung-Ang University Gwangmyeong Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiwon Han, MD, PhD

CONTACT

+82-10-3447-1988; yesuroon@gmail.com

Haesun Jung, MD

CONTACT

82-10-9452-0448; sunnyj0107@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to group allocation. Because of the different anesthetic techniques used in each study arm, anesthesiologists administering anesthesia cannot be blinded. Postoperative recovery outcomes will be assessed by blinded outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthesiology and Pain Medicine, Chung-Ang University Gwangmyeong Hospital

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either remimazolam anesthesia with planned flumazenil reversal or sevoflurane-based balanced anesthesia.

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 23, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)