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

May 24, 2023 updated by: Jeong-Hwa Seo, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: remimazolam group
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
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.
Other Names:
  • remimazolam group
Active Comparator: propofol group
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
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).
Other Names:
  • propofol group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in eye opening time between the two groups
Time Frame: Up to the first eye opening from stopping injection of anesthetics
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
Time Frame: Up to extubation from stopping injection of anesthetics
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
Time Frame: Within 5 minutes of arrival at the post-anesthetic care unit
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
Time Frame: immediately after discharge from the post-anesthetic care unit
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
Time Frame: 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
Time Frame: at 24 hours postoperatively
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
Time Frame: during the operation
Intraoperative hemodynamic measured by performance error (%), median performance error (%), median absolute performance error (%), and wobble (%)
during the operation
Intraoperative anesthetic depth stability
Time Frame: during the operation
Intraoperative anesthetic depth stability measured by performance error (%), median performance error (%), median absolute performance error (%), and wobble (%)
during the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Hana Pharm Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2021

Primary Completion (Actual)

August 12, 2022

Study Completion (Actual)

September 11, 2022

Study Registration Dates

First Submitted

August 23, 2021

First Submitted That Met QC Criteria

September 15, 2021

First Posted (Actual)

September 17, 2021

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2105-016-1217

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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