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RecoveryNCT05435911

Comparison of Recovery From General Anesthesia in Remimazolam With Flumazenil vs. Propofol

A study testing REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO], Flumazenil and Propofol in people with Recovery, 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 trial aims to compare recovery time from discontinuation of remimazolam followed by flumazenil administration vs. propofol-based total intravenous anesthesia in patients undergoing breast cancer surgery. Read more about this study

Who is it for?
Ages 19 years and older, women only
Conditions the study is for
Recovery
What is being tested?
REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO], Flumazenil and Propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteSouth Korea
Study dates
2 Aug 2022to 21 Dec 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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patient, age >19, scheduled for breast cancer surgery under general anesthesia

Who cannot join

  • Patients who are not alert before procedure
  • Day surgery
  • BMI ≥35
  • Hemodynamicaly unstable patients before procedure
  • Patients with history of neromuscular disease or drug use affecting neuromuscular function.
  • Patients with history of adverse reaction of allergic reaction to study drugs
Show all 13Show fewer
  • Patients who are anticipated to be unable to remove supraglottic airway or endotracheal tube due to severe dyspnea or need for mechanical ventilatory support
  • Use of sedatives (anxiolytics, psychoactive medication, antidepressants, hypnotics) within 24 h
  • Known galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • Alcohol or drug dependence
  • Organic brain disorder
  • Patients with hypersensitive to beans or peanut
  • Patients who refuse to participate

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Department of Anesthesiology and Pain Medicine, Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

Official title: Comparison of Recovery From General Anesthesia in Remimazolam With Flumazenil Compared to Propofol-based Total Intravenous Anesthesia in Patients Undergoing Breast Cancer Surgery: a Randomized Controlled Trial

This prospective randomized trial aims to compare recovery time from discontinuation of remimazolam followed by flumazenil administration vs. propofol-based total intravenous anesthesia in patients undergoing breast cancer surgery.

Read the detailed description

Adult patients undergoing breast cancer surgery are randomized to receive either remimazolam with flumazenil or propofol-based total intravenous anesthesia. When the surgery is ended, anesthetic agents are discontinued. The study's primary outcome is a comparison of the time to the first eye-opening response to the doctor's command from the discontinuation of anesthetic agents between the groups. Secondary outcomes include the time from anesthetics off to extubation/discharge from operating room (OR), BIS score at eye-opening/extubation/discharge from OR, the incidence of emergence agitation at OR, the PAT score, the modified Aldrete score, modified OAA/S (Observers Assessment of Alertness/Sedation Scale) after PACU administration. In addition, the investigators investigate postoperative pain score at 10/20/30 minutes and postoperative nausea and vomiting after PACU administration, Korean version of quality of recovery-15 in postoperative 24 hours, postoperative pain score and postoperative nausea and vomiting, postoperative opioid consumption in postoperative 24 hours.

Conditions
Recovery
Being tested
REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO], Flumazenil, Propofol
Keywords
recovery, remimazolam, flumazenil, propofol, safety

What participants receive

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

  • REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]Drug

    Also called Remimazolam Besylate

    Remimazolam Besylate is used as an intervention drug for general anesthesia, followed by flumazenil administration at the end of anesthesia, compared to propofol-based total intravenous anesthesia during breast cancer surgery under general anesthesia

  • FlumazenilDrug

    Flumazenil is used as an additional intervention drug to facilitate emergence from general anesthesia in the Remimazolam with Flumazenil group.

  • PropofolDrug

    Propofol is used as an active comparator drug for general anesthesia until the end of anesthesia, to be compared to remimazolam besylate during breast cancer surgery under general anesthesia.

Study groups in NCT05435911
Study groupRoleWhat they receive
Remimazolam with flumazenilExperimentalPatients allocated to remimazolam with flumazenil group receive remimazolam as the main anesthetics during general anesthesia and then flumazenil administration at the end of anesthesia. Remifentanil continuous infusion can be used for hemodynamic stability and analgesia.
Receives: Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]; Drug: Flumazenil
Propofol-based total intravenous anesthesiaActive comparatorPatients allocated to the propofol-based total intravenous anesthesia group receive propofol as the main anesthetics during general anesthesia until the end of anesthesia. Remifentanil continuous infusion can be used for hemodynamic stability and analgesia.
Receives: Drug: Propofol

What is being measured

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

  1. Time to eye opening (minute)

    The time to the first eye-opening response to the doctor's command from the discontinuation of anesthetic agents

    Measured: 20 minutes after anesthesia emergence

Secondary outcomes (11)

  1. Time to emergence (minutes)

    The time from anesthetics off to extubation/discharge from operating room

    Measured: 20 minutes after anesthesia emergence

  2. Bispectral index score (Score)

    A BIS score quantifies changes in the electrophysiologic state of the brain during anesthesia. In patients who are awake, a typical BIS score is 90 to 100. Complete suppression of cortical activity results in a BIS score of 0, known as a flat line. Lower numbers indicate a higher hypnotic effect.

    Measured: During 20 minutes after anesthesia emergence (3 point : Time from anesthetics off to eye opening/extubation/discharge from operating room)

  3. Incidence of emergence agitation at operating room (n(%))

    Ricker sedation agitated scale ≥5 was defined as emergence agitation, (1-7)

    Measured: Time Frame: 20 minutes after anesthesia emergence

  4. The modified Aldrete score (Score)

    The modified Aldrete score (0-10), Score ≥9 was defined as the possibility of discharge from PACU

    Measured: 30 minutes after post anaestheisa care unit adminstration

  5. The modified Observers Assessment of Alertness/Sedation Scale (Score)

    The modified Observers Assessment of Alertness/Sedation Scale (0-5), Score 5 was defined as respond readily to name spoken in normal tone.

    Measured: 30 minutes after post anaestheisa care unit adminstration

  6. Postoperative Pain (score)

    Numerical rating scales score (0-10) of pain, The higher score was defined as severe pain

    Measured: 10/20/30 minutes after post anaestheisa care unit administation

  7. Postoperative opioid consumption (The number of analgesic use)

    Postoperative opioid requirement

    Measured: from post anaestheisa care unit administation to post anaestheisa care unit discharge (during 30-40 minutes, upto 1 hours)

  8. Postoperative nausea and vomiting (The incidence of PONV, n(%))

    Postoperative nausea and vomiting

    Measured: from post anaestheisa care unit administation to post anaestheisa care unit discharge (during 30-40 minutes, upto 1 hours)

  9. Postoperative quality of recovery (score)

    Korean version of quality of recovery-15, The higher score was defined as good satisfaction.

    Measured: upto 24 hours

  10. Postoperative opioid consumption (The number of analgesic use)

    Postoperative opioid requirement

    Measured: upto 24 hours

  11. Postoperative Pain (score)

    Numerical rating scales score (0-10) of pain, The higher score was defined as severe pain

    Measured: upto 24 hours

Timeline

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

  1. First posted28 Jun 2022
  2. Study start2 Aug 2022
  3. Primary completion21 Dec 2022
  4. Study completion21 Dec 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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05435911
Sponsor's protocol ID
Remimazolam_recovery
Status last verified
Jan 2023
First submitted
7 Jun 2022
Last updated
13 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee J, Kim DH, Ju JW, Nam K, Cho YJ, Jeon Y, Lee S. Comparison of recovery profiles between total intravenous anaesthesia with propofol or remimazolam reversed with flumazenil in patients undergoing breast surgery: A randomised controlled trial. Eur J Anaesthesiol. 2024 Mar 1;41(3):199-207. doi: 10.1097/EJA.0000000000001951. Epub 2024 Jan 11.

    PubMed 38205822

Questions about this trial

What is this clinical trial studying?

A study testing REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO], Flumazenil and Propofol in people with Recovery, 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 1 inclusion and 13 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 13 Jan 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?

Time to eye opening (minute) (time frame: 20 minutes after anesthesia emergence). 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 NCT05435911, which also lists 1 linked publication.

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 13 Jan 2023.

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