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

Seoul National University Hospital66 enrolled

Overview

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.

Adult patients undergoing breast cancer surgery are randomized to receive either remimazolam with flumazenil or propofol-based total intravenous anesthesia. When the surgery is ended, anesthetic agents are discontinued. The study's primary outcome is a comparison of the time to the first eye-opening response to the doctor's command from the discontinuation of anesthetic agents between the groups. Secondary outcomes include the time from anesthetics off to extubation/discharge from operating room (OR), BIS score at eye-opening/extubation/discharge from OR, the incidence of emergence agitation at OR, the PAT score, the modified Aldrete score, modified OAA/S (Observers Assessment of Alertness/Sedation Scale) after PACU administration. In addition, the investigators investigate postoperative pain score at 10/20/30 minutes and postoperative nausea and vomiting after PACU administration, Korean version of quality of recovery-15 in postoperative 24 hours, postoperative pain score and postoperative nausea and vomiting, postoperative opioid consumption in postoperative 24 hours.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Recovery

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

FlumazenilDRUG

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

PropofolDRUG

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.

Eligibility

Sex: FEMALEMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patient, age \>19, scheduled for breast cancer surgery under general anesthesia Exclusion Criteria: * 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

Locations (1)

Department of Anesthesiology and Pain Medicine, Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Time to eye opening (minute)

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

Time frame: 20 minutes after anesthesia emergence

Secondary Outcomes

Time to emergence (minutes)

The time from anesthetics off to extubation/discharge from operating room

Time frame: 20 minutes after anesthesia emergence

Bispectral index score (Score)

A BIS score quantifies changes in the electrophysiologic state of the brain during anesthesia. In patients who are awake, a typical BIS score is 90 to 100. Complete suppression of cortical activity results in a BIS score of 0, known as a flat line. Lower numbers indicate a higher hypnotic effect.

Time frame: 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(%))

Ricker sedation agitated scale ≥5 was defined as emergence agitation, (1-7)

Time frame: Time Frame: 20 minutes after anesthesia emergence

The modified Aldrete score (Score)

The modified Aldrete score (0-10), Score ≥9 was defined as the possibility of discharge from PACU

Time frame: 30 minutes after post anaestheisa care unit adminstration

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

The modified Observers Assessment of Alertness/Sedation Scale (0-5), Score 5 was defined as respond readily to name spoken in normal tone.

Time frame: 30 minutes after post anaestheisa care unit adminstration

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.