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NCT Number: NCT05047939

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

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.

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Key information

Conditions

Anesthesia, Intravenous

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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).

Other names: propofol group

Primary outcomes

  1. Difference in eye opening time between the two groups

    Time frame: 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 outcomes

  1. Difference in extubation time between the two groups

    Time frame: 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)

  2. Modified Aldrete score

    Time frame: 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

  3. length of post-anesthetic care unit stay

    Time frame: immediately after discharge from the post-anesthetic care unit

    length of post-anesthetic care unit stay (minute)

  4. Postoperative nausea and vomiting during the first 24 hours postoperatively

    Time frame: during the first 24 hours postoperatively

    Incidence of postoperative nausea and vomiting during the first 24 hours postoperatively

  5. postoperative quality of recovery

    Time frame: 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)

  6. Intraoperative hemodynamic stability

    Time frame: during the operation

    Intraoperative hemodynamic measured by performance error (%), median performance error (%), median absolute performance error (%), and wobble (%)

  7. Intraoperative anesthetic depth stability

    Time frame: during the operation

    Intraoperative anesthetic depth stability measured by performance error (%), median performance error (%), median absolute performance error (%), and wobble (%)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Hana Pharm Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 17, 2021
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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