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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-02

Study Completion Date

2022-12-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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.

Interventions

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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

Intervention Type DRUG

Flumazenil

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Remimazolam Besylate

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No