Comparison of Recovery From General Anesthesia in Remimazolam With Flumazenil vs. Propofol

NCT05435911 | Completed DMC

• 1 other identifier: Remimazolam_recovery
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized trial aims to compare recovery time from discontinuation of remimazolam followed by flumazenil administration vs. propofol-based total intravenous anesthesia in patients undergoing breast cancer surgery.

Conditions

Recovery

Keywords

recovery; remimazolam; flumazenil; propofol; safety

Outcome Measures

Primary Outcomes (1)

• Time to eye opening (minute)

  The time to the first eye-opening response to the doctor's command from the discontinuation of anesthetic agents

  20 minutes after anesthesia emergence

Secondary Outcomes (11)

• Time to emergence (minutes)

  20 minutes after anesthesia emergence

• Bispectral index score (Score)

  During 20 minutes after anesthesia emergence (3 point : Time from anesthetics off to eye opening/extubation/discharge from operating room)

• Incidence of emergence agitation at operating room (n(%))

  Time Frame: 20 minutes after anesthesia emergence

• The modified Aldrete score (Score)

  30 minutes after post anaestheisa care unit adminstration

• The modified Observers Assessment of Alertness/Sedation Scale (Score)

  30 minutes after post anaestheisa care unit adminstration

Study Arms (2)

Remimazolam with flumazenil

EXPERIMENTAL

Patients allocated to remimazolam with flumazenil group receive remimazolam as the main anesthetics during general anesthesia and then flumazenil administration at the end of anesthesia. Remifentanil continuous infusion can be used for hemodynamic stability and analgesia.

Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]; Drug: Flumazenil

Propofol-based total intravenous anesthesia

ACTIVE COMPARATOR

Patients allocated to the propofol-based total intravenous anesthesia group receive propofol as the main anesthetics during general anesthesia until the end of anesthesia. Remifentanil continuous infusion can be used for hemodynamic stability and analgesia.

Drug: Propofol

Interventions

REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO] DRUG

Remimazolam Besylate is used as an intervention drug for general anesthesia, followed by flumazenil administration at the end of anesthesia, compared to propofol-based total intravenous anesthesia during breast cancer surgery under general anesthesia

Also known as: Remimazolam Besylate

Remimazolam with flumazenil

Flumazenil DRUG

Flumazenil is used as an additional intervention drug to facilitate emergence from general anesthesia in the Remimazolam with Flumazenil group.

Remimazolam with flumazenil

Propofol DRUG

Propofol is used as an active comparator drug for general anesthesia until the end of anesthesia, to be compared to remimazolam besylate during breast cancer surgery under general anesthesia.

Propofol-based total intravenous anesthesia

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient, age \>19, scheduled for breast cancer surgery under general anesthesia

You may not qualify if:

• Patients who are not alert before procedure
• Day surgery
• BMI ≥35
• Hemodynamicaly unstable patients before procedure
• Patients with history of neromuscular disease or drug use affecting neuromuscular function.
• Patients with history of adverse reaction of allergic reaction to study drugs
• Patients who are anticipated to be unable to remove supraglottic airway or endotracheal tube due to severe dyspnea or need for mechanical ventilatory support
• Use of sedatives (anxiolytics, psychoactive medication, antidepressants, hypnotics) within 24 h
• Known galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• Alcohol or drug dependence
• Organic brain disorder
• Patients with hypersensitive to beans or peanut
• Patients who refuse to participate

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

• Lee J, Kim DH, Ju JW, Nam K, Cho YJ, Jeon Y, Lee S. Comparison of recovery profiles between total intravenous anaesthesia with propofol or remimazolam reversed with flumazenil in patients undergoing breast surgery: A randomised controlled trial. Eur J Anaesthesiol. 2024 Mar 1;41(3):199-207. doi: 10.1097/EJA.0000000000001951. Epub 2024 Jan 11.

  PMID: 38205822 DERIVED

MeSH Terms

Interventions

Injections, Intravenous; Powders; Flumazenil; Propofol

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Injections; Dosage Forms; Pharmaceutical Preparations; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Yunseok Jeon, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 28, 2022
• Study Start: August 2, 2022
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)