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

NCT ID: NCT05047939

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-14
• Study Completion Date: 2022-09-11

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.

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.

Conditions

Anesthesia, Intravenous

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

remimazolam-based TIVA

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

propofol-based TIVA

Intervention Type: 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).

Interventions

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.

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

remimazolam group; propofol group

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hana Pharm Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeong-Hwa Seo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 27496519 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37131126 (View on PubMed)

Other Identifiers

H-2105-016-1217

Identifier Type: -

Identifier Source: org_study_id