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Completed

NCT Number: NCT05435911

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

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.

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Key information

Conditions

Recovery

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

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

Drug

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

Other names: Remimazolam Besylate

Flumazenil

Drug

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

Propofol

Drug

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.

Primary outcomes

  1. Time to eye opening (minute)

    Time frame: 20 minutes after anesthesia emergence

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

Secondary outcomes

  1. Time to emergence (minutes)

    Time frame: 20 minutes after anesthesia emergence

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

  2. Bispectral index score (Score)

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

    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.

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

    Time frame: Time Frame: 20 minutes after anesthesia emergence

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

  4. The modified Aldrete score (Score)

    Time frame: 30 minutes after post anaestheisa care unit adminstration

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

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

    Time frame: 30 minutes after post anaestheisa care unit adminstration

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

  6. Postoperative Pain (score)

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

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

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

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

    Postoperative opioid requirement

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

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

    Postoperative nausea and vomiting

  9. Postoperative quality of recovery (score)

    Time frame: upto 24 hours

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

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

    Time frame: upto 24 hours

    Postoperative opioid requirement

  11. Postoperative Pain (score)

    Time frame: upto 24 hours

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2022
Registry last updated
Jan 13, 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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