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

Not Applicable

Completed

• Conditions: Anesthesia, Intravenous
• Interventions: Drug: remimazolam-based TIVA; Drug: propofol-based TIVA

• Registration Number: NCT05047939
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-17
• Study Start: 2021-12-14
• Primary Completion: 2022-08-12
• Study Completion: 2022-09-11
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
remimazolam group	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 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.
propofol 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). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.

Primary Outcome Measures

Name	Time	Method
Difference in eye opening time between the two groups	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)

Secondary Outcome Measures

Name	Time	Method
Intraoperative hemodynamic stability	during the operation	Intraoperative hemodynamic measured by performance error (%), median performance error (%), median absolute performance error (%), and wobble (%)
Difference in extubation time between the two groups	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)
Modified Aldrete score	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
length of post-anesthetic care unit stay	immediately after discharge from the post-anesthetic care unit	length of post-anesthetic care unit stay (minute)
Postoperative nausea and vomiting during the first 24 hours postoperatively	during the first 24 hours postoperatively	Incidence of postoperative nausea and vomiting during the first 24 hours postoperatively
postoperative quality of recovery	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)
Intraoperative anesthetic depth stability	during the operation	Intraoperative anesthetic depth stability measured by performance error (%), median performance error (%), median absolute performance error (%), and wobble (%)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of