Clinical trial NCT05435911: Comparison of Recovery From General Anesthesia in Remimazolam With Flumazenil vs. Propofol
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recovery
Keywords: recovery
remimazolam
flumazenil
propofol
safety
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 66
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Time to eye opening (minute)
timeFrame: 20 minutes after anesthesia emergence
Secondary outcomes:
measure: Time to emergence (minutes)
timeFrame: 20 minutes after anesthesia emergence
measure: Bispectral index score (Score)
timeFrame: During 20 minutes after anesthesia emergence (3 point : Time from anesthetics off to eye opening/extubation/discharge from operating room)
measure: Incidence of emergence agitation at operating room (n(%))
timeFrame: Time Frame: 20 minutes after anesthesia emergence
measure: The modified Aldrete score (Score)
timeFrame: 30 minutes after post anaestheisa care unit adminstration
measure: The modified Observers Assessment of Alertness/Sedation Scale (Score)
timeFrame: 30 minutes after post anaestheisa care unit adminstration
measure: Postoperative Pain (score)
timeFrame: 10/20/30 minutes after post anaestheisa care unit administation
measure: Postoperative opioid consumption (The number of analgesic use)
timeFrame: from post anaestheisa care unit administation to post anaestheisa care unit discharge (during 30-40 minutes, upto 1 hours)
measure: Postoperative nausea and vomiting (The incidence of PONV, n(%))
timeFrame: from post anaestheisa care unit administation to post anaestheisa care unit discharge (during 30-40 minutes, upto 1 hours)
measure: Postoperative quality of recovery (score)
timeFrame: upto 24 hours
measure: Postoperative opioid consumption (The number of analgesic use)
timeFrame: upto 24 hours
measure: Postoperative Pain (score)
timeFrame: upto 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yunseok Jeon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: