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

Recovery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05435911
• Other study ID #: Remimazolam_recovery
• Status: Completed
• Phase: N/A
• Start date: August 2, 2022
• Est. completion date: December 21, 2022

Study information

• Verified date: January 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 21, 2022
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Recovery

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to eye opening (minute)	The time to the first eye-opening response to the doctor's command from the discontinuation of anesthetic agents	20 minutes after anesthesia emergence
Secondary	Time to emergence (minutes)	The time from anesthetics off to extubation/discharge from operating room	20 minutes after anesthesia emergence
Secondary	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.	During 20 minutes after anesthesia emergence (3 point : Time from anesthetics off to eye opening/extubation/discharge from operating room)
Secondary	Incidence of emergence agitation at operating room (n(%))	Ricker sedation agitated scale =5 was defined as emergence agitation, (1-7)	Time Frame: 20 minutes after anesthesia emergence
Secondary	The modified Aldrete score (Score)	The modified Aldrete score (0-10), Score =9 was defined as the possibility of discharge from PACU	30 minutes after post anaestheisa care unit adminstration
Secondary	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.	30 minutes after post anaestheisa care unit adminstration
Secondary	Postoperative Pain (score)	Numerical rating scales score (0-10) of pain, The higher score was defined as severe pain	10/20/30 minutes after post anaestheisa care unit administation
Secondary	Postoperative opioid consumption (The number of analgesic use)	Postoperative opioid requirement	from post anaestheisa care unit administation to post anaestheisa care unit discharge (during 30-40 minutes, upto 1 hours)
Secondary	Postoperative nausea and vomiting (The incidence of PONV, n(%))	Postoperative nausea and vomiting	from post anaestheisa care unit administation to post anaestheisa care unit discharge (during 30-40 minutes, upto 1 hours)
Secondary	Postoperative quality of recovery (score)	Korean version of quality of recovery-15, The higher score was defined as good satisfaction.	upto 24 hours
Secondary	Postoperative opioid consumption (The number of analgesic use)	Postoperative opioid requirement	upto 24 hours
Secondary	Postoperative Pain (score)	Numerical rating scales score (0-10) of pain, The higher score was defined as severe pain	upto 24 hours