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

Seoul National University

Status: Completed

Conditions: Recovery

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05435911

Remimazolam_recovery

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 2 patient groups

Remimazolam with flumazenil

Experimental group

Description:

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.

Treatment:

Drug: Flumazenil

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

Propofol-based total intravenous anesthesia

Active Comparator group

Description:

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.

Treatment:

Drug: Propofol