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Anesthesia, IntravenousNCT05047939

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

A study testing remimazolam-based TIVA and propofol-based TIVA in people with Anesthesia, Intravenous, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 19 to 70 years
Conditions the study is for
Anesthesia, Intravenous
What is being tested?
remimazolam-based TIVA and propofol-based TIVA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteSouth Korea
Study dates
14 Dec 2021to 11 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
remimazolam-based TIVA, propofol-based TIVA
Keywords
Anesthetics, Anesthetics, General, Benzodiazepines, Flumazenil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • remimazolam-based TIVADrug

    Also called 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, is administered at the end of surgery.

  • propofol-based TIVADrug

    Also called 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).

Study groups in NCT05047939
Study groupRoleWhat they receive
remimazolam groupExperimentalIn 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.
Receives: Drug: remimazolam-based TIVA
propofol groupActive comparatorIn 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.
Receives: Drug: propofol-based TIVA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Up to the first eye opening from stopping injection of anesthetics

Secondary outcomes (7)

  1. 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)

    Measured: Up to extubation from stopping injection of anesthetics

  2. Modified Aldrete score

    Modified Aldrete score (0-10, higher scores mean a better outcome) measured when admit the post-anesthetic care unit

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

  3. length of post-anesthetic care unit stay

    length of post-anesthetic care unit stay (minute)

    Measured: immediately after discharge from the post-anesthetic care unit

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

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

    Measured: during the first 24 hours postoperatively

  5. 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)

    Measured: at 24 hours postoperatively

  6. Intraoperative hemodynamic stability

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

    Measured: during the operation

  7. Intraoperative anesthetic depth stability

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

    Measured: during the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2021
  2. Study start14 Dec 2021
  3. Primary completion12 Aug 2022
  4. Study completion11 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A prospective randomized single-blinded study
Masking
Single blind
Who is masked
Participant
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05047939
Sponsor's protocol ID
H-2105-016-1217
Status last verified
May 2023
First submitted
23 Aug 2021
Last updated
26 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27496519

  • 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.

    PubMed 37131126

Questions about this trial

What is this clinical trial studying?

A study testing remimazolam-based TIVA and propofol-based TIVA in people with Anesthesia, Intravenous, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in eye opening time between the two groups (time frame: Up to the first eye opening from stopping injection of anesthetics). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05047939, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.

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