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
Overview
- Phase
- Not Applicable
- Intervention
- REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]
- Conditions
- Recovery
- Sponsor
- Seoul National University Hospital
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Time to eye opening (minute)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
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.
Investigators
Yunseok Jeon
Professor
Seoul National University Hospital
Eligibility Criteria
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
- •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
Arms & Interventions
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.
Intervention: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]
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.
Intervention: Flumazenil
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.
Intervention: Propofol
Outcomes
Primary Outcomes
Time to eye opening (minute)
Time Frame: 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 Outcomes
- Incidence of emergence agitation at operating room (n(%))(Time Frame: 20 minutes after anesthesia emergence)
- The modified Observers Assessment of Alertness/Sedation Scale (Score)(30 minutes after post anaestheisa care unit adminstration)
- Postoperative Pain (score)(upto 24 hours)
- Postoperative opioid consumption (The number of analgesic use)(upto 24 hours)
- Bispectral index score (Score)(During 20 minutes after anesthesia emergence (3 point : Time from anesthetics off to eye opening/extubation/discharge from operating room))
- The modified Aldrete score (Score)(30 minutes after post anaestheisa care unit adminstration)
- Time to emergence (minutes)(20 minutes after anesthesia emergence)
- 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 quality of recovery (score)(upto 24 hours)