Comparison of Recovery Profile After TIVA Between Remimazolam With Flumazenil and Propofol

Study Overview
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Brief Summary
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This prospective, randomized, single-blinded study is designed to compare the recovery profile between propofol-based total intravenous anesthesia (TIVA) and remimazolam-based TIVA in patients undergoing thyroidectomy. In the remimazolam group, its antagonist, flumazenil, is administered at the end of surgery. We hypothesize that remimazolam-based TIVA antagonized by flumazenil can significantly shorten the time from the end of anesthetic administration to eye-opening compared to propofol-based TIVA.

Detailed Description
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Adult patients undergoing elective thyroidectomy are randomly allocated to receive propofol-based TIVA (n=35) or remimazolam-based TIVA (n=35). The recovery profile including the time from the end of anesthetic administration to eye-opening, the time from the end of anesthetic administration to extubation, hemodynamic stability, stability of anesthetic depth, duration of post-anesthetic care stay, the incidence of postoperative nausea and vomiting during the first 24 hours, and the quality of recover 24 hours after surgery using the quality of recovery-15 was assessed by an investigator. The primary outcome is the time from the end of anesthetic administration to eye-opening.

Official Title
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Comparison of Recovery Profile After Total Intravenous Anesthesia Between Remimazolam With Flumazenil and Propofol in Patients Undergoing Thyroidectomy: A Single-blinded Randomized Controlled Trial

Conditions
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Anesthesia, Intravenous

Intervention / Treatment
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* Drug: remimazolam-based TIVA
* Drug: propofol-based TIVA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled to undergo elective thyroidectomy under general anesthesia American Society of Anesthesiologists (ASA)physical classification I-II Willingness and ability to sign an informed consent document Exclusion Criteria: American Society of Anesthesiologists (ASA)physical classification III or more BMI > 40kg/m^2 Allergies to anesthetic or analgesic medications (benzodiazepines, propofol, remifentanil, fentanyl citrate, rocuronium bromide, sugammadex, flumazenil) Patients who receive mechanical ventilation morethan 2 hours after surgery Patients who receive the following medications within 24 hours prior to general anesthetics: anxiolytics, antipsychotics, rifampicin, succinycholine, neostigmine, flumazenil, cyclosporin Patients with galactose intolerance or Lapp Lactase deficiency or glucose-galactose malabsorption Medical or psychological disease that can affect the treatment response

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective randomized single-blinded study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: remimazolam group<br>In the remimazolam-based TIVA group, general anesthesia is induced and maintained with a continuous infusion of remimazolam using an infusion pump. In the remimazolam group, its antagonist, flumazenil 0.2mg, is administered at the end of surgery. In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure. | Drug: remimazolam-based TIVA<br>* In the remimazolam-based TIVA group, general anesthesia is induced and maintained with a continuous infusion of remimazolam using an infusion pump. In the remimazolam group, its antagonist, flumazenil, is administered at the end of surgery.<br>* Other names: remimazolam group;|
| Active Comparator: propofol group<br>In the propofol-based TIVA group, general anesthesia is induced and maintained with a target-controlled infusion of propofol using an infusion pump (Orchestra®; Fresenius Vial, France). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure. | Drug: propofol-based TIVA<br>* In the propofol-based TIVA group, general anesthesia is induced and maintained with a target-controlled infusion of propofol using an infusion pump (Orchestra®; Fresenius Vial, France).<br>* Other names: propofol group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in eye opening time between the two groups | difference in eye opening time after stopping injection of anesthetics (From the end of anesthetic administration to the first eye opening) | Up to the first eye opening from stopping injection of anesthetics | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in extubation time between the two groups | difference in extubation time after stopping injection of anesthetics (From the end of anesthetic administration to extubation) | Up to extubation from stopping injection of anesthetics | 
| Modified Aldrete score | Modified Aldrete score (0-10, higher scores mean a better outcome) measured when admit the post-anesthetic care unit | Within 5 minutes of arrival at the post-anesthetic care unit | 
| length of post-anesthetic care unit stay | length of post-anesthetic care unit stay (minute) | immediately after discharge from the post-anesthetic care unit | 
| Postoperative nausea and vomiting during the first 24 hours postoperatively | Incidence of postoperative nausea and vomiting during the first 24 hours postoperatively | during the first 24 hours postoperatively | 
| postoperative quality of recovery | quality of recovery measured by the Korean version of the Quality of Recovery-15 (QoR-15K, 0-150, higher scores mean a better outcome) | at 24 hours postoperatively | 
| Intraoperative hemodynamic stability | Intraoperative hemodynamic measured by performance error (%), median performance error (%), median absolute performance error (%), and wobble (%) | during the operation | 
| Intraoperative anesthetic depth stability | Intraoperative anesthetic depth stability measured by performance error (%), median performance error (%), median absolute performance error (%), and wobble (%) | during the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthetics, Anesthetics, General, Benzodiazepines, Flumazenil