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

Anesthesia, Intravenous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05047939
• Other study ID #: H-2105-016-1217
• Status: Completed
• Phase: N/A
• Start date: December 14, 2021
• Est. completion date: September 11, 2022

Study information

• Verified date: May 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 11, 2022
• Est. primary completion date: August 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Intravenous

Intervention

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.
• 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).

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Hana Pharm Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	length of post-anesthetic care unit stay	length of post-anesthetic care unit stay (minute)	immediately after discharge from the post-anesthetic care unit
Secondary	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
Secondary	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
Secondary	Intraoperative hemodynamic stability	Intraoperative hemodynamic measured by performance error (%), median performance error (%), median absolute performance error (%), and wobble (%)	during the operation
Secondary	Intraoperative anesthetic depth stability	Intraoperative anesthetic depth stability measured by performance error (%), median performance error (%), median absolute performance error (%), and wobble (%)	during the operation