Clinical trial

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

Name

H-2105-016-1217

Description

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.

Trial arms

Trial start

2021-12-14

Estimated PCD

2022-08-12

Trial end

2022-09-11

Status

Completed

Treatment

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.

Arms:

remimazolam group

Other names:

remimazolam group

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).

Arms:

propofol group

Other names:

propofol group

Size

Primary endpoint

Difference in eye opening time between the two groups

Up to the first eye opening from stopping injection of anesthetics

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective randomized single-blinded study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Patients will receive general anesthesia, therefore they cannot know their anesthetic agents.\n\nPhysicians involved in this study will investigate the outcomes.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 58, 'type': 'ACTUAL'}}

Updated at

2023-05-26

1 organization

2 products

2 indications

Organization

Seoul National University Hospital

Product

Indication

Indication

Product