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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05435911

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Recovery	Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO] Drug: Flumazenil Drug: Propofol	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison of Recovery From General Anesthesia in Remimazolam With Flumazenil Compared to Propofol-based Total Intravenous Anesthesia in Patients Undergoing Breast Cancer Surgery: a Randomized Controlled Trial

Anticipated Study Start Date :

Aug 2, 2022

Anticipated Primary Completion Date :

Aug 2, 2022

Anticipated Study Completion Date :

Aug 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remimazolam with flumazenil 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] 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 Other Names: Remimazolam Besylate Drug: Flumazenil Flumazenil is used as an additional intervention drug to facilitate emergence from general anesthesia in the Remimazolam with Flumazenil group.
Active Comparator: Propofol-based total intravenous anesthesia 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 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.

Arm

Intervention/Treatment

Experimental: Remimazolam with flumazenil

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]

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

Other Names:

Remimazolam Besylate

Drug: Flumazenil

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

Active Comparator: Propofol-based total intravenous anesthesia

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

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.

Outcome Measures

Primary Outcome Measures

Time to eye opening (minute) [20 minutes after anesthesia emergence]
The time to the first eye-opening response to the doctor's command from the discontinuation of anesthetic agents

Secondary Outcome Measures

Time to emergence (minutes) [20 minutes after anesthesia emergence]
The time from anesthetics off to extubation/discharge from operating room
Bispectral index score (Score) [During 20 minutes after anesthesia emergence (3 point : Time from anesthetics off to eye opening/extubation/discharge from operating room)]
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.
Incidence of emergence agitation at operating room (n(%)) [Time Frame: 20 minutes after anesthesia emergence]
Ricker sedation agitated scale ≥5 was defined as emergence agitation, (1-7)
The modified Aldrete score (Score) [30 minutes after post anaestheisa care unit adminstration]
The modified Aldrete score (0-10), Score ≥9 was defined as the possibility of discharge from PACU
The modified Observers Assessment of Alertness/Sedation Scale (Score) [30 minutes after post anaestheisa care unit adminstration]
The modified Observers Assessment of Alertness/Sedation Scale (0-5), Score 5 was defined as respond readily to name spoken in normal tone.
Postoperative Pain (score) [10/20/30 minutes after post anaestheisa care unit administation]
Numerical rating scales score (0-10) of pain, The higher score was defined as severe pain
Postoperative opioid consumption (The number of analgesic use) [from post anaestheisa care unit administation to post anaestheisa care unit discharge (during 30-40 minutes, upto 1 hours)]
Postoperative opioid requirement
Postoperative nausea and vomiting (The incidence of PONV, n(%)) [from post anaestheisa care unit administation to post anaestheisa care unit discharge (during 30-40 minutes, upto 1 hours)]
Postoperative nausea and vomiting
Postoperative quality of recovery (score) [upto 24 hours]
Korean version of quality of recovery-15, The higher score was defined as good satisfaction.
Postoperative opioid consumption (The number of analgesic use) [upto 24 hours]
Postoperative opioid requirement
Postoperative Pain (score) [upto 24 hours]
Numerical rating scales score (0-10) of pain, The higher score was defined as severe pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patient, age 19-70 years, 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