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

NCT05047939 | Completed DMC

• 1 other identifier: H-2105-016-1217
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia, Intravenous

Keywords

Anesthetics; Anesthetics, General; Benzodiazepines; Flumazenil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Difference in extubation time between the two groups

  Up to extubation from stopping injection of anesthetics

• Modified Aldrete score

  Within 5 minutes of arrival at the post-anesthetic care unit

• length of post-anesthetic care unit stay

  immediately after discharge from the post-anesthetic care unit

• Postoperative nausea and vomiting during the first 24 hours postoperatively

  during the first 24 hours postoperatively

• postoperative quality of recovery

  at 24 hours postoperatively

Study Arms (2)

remimazolam group

EXPERIMENTAL

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

propofol group

ACTIVE COMPARATOR

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

Interventions

remimazolam-based TIVA DRUG

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.

Also known as: remimazolam group

remimazolam group

propofol-based TIVA DRUG

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).

Also known as: propofol group

propofol group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Hana Pharm Co., Ltd.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (2)

• Wesolowski AM, Zaccagnino MP, Malapero RJ, Kaye AD, Urman RD. Remimazolam: Pharmacologic Considerations and Clinical Role in Anesthesiology. Pharmacotherapy. 2016 Sep;36(9):1021-7. doi: 10.1002/phar.1806. Epub 2016 Sep 1.

  PMID: 27496519 BACKGROUND

• Lee HJ, Lee HB, Kim YJ, Cho HY, Kim WH, Seo JH. Comparison of the recovery profile of remimazolam with flumazenil and propofol anesthesia for open thyroidectomy. BMC Anesthesiol. 2023 May 2;23(1):147. doi: 10.1186/s12871-023-02104-1.

  PMID: 37131126 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will receive general anesthesia, therefore they cannot know their anesthetic agents. Physicians involved in this study will investigate the outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective randomized single-blinded study

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: September 17, 2021
• Study Start: December 14, 2021
• Primary Completion: August 12, 2022
• Study Completion: September 11, 2022
• Last Updated: May 26, 2023

Record last verified: 2023-05

Locations

KR (1)