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

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ClinicalTrials.gov Identifier: NCT05435911
Recruitment Status : Not yet recruiting
First Posted : June 28, 2022
Last Update Posted : August 1, 2022
Sponsor:
Information provided by (Responsible Party):
Yunseok Jeon, Seoul National University Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Recovery Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO] Drug: Flumazenil Drug: Propofol Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 2, 2022
Estimated Primary Completion Date : August 2, 2022
Estimated Study Completion Date : August 2, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Remimazolam with flumazenil
Patients 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.
 Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]
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 Name: Remimazolam Besylate

Drug: Flumazenil
Flumazenil is used as an additional intervention drug to facilitate emergence from general anesthesia in the Remimazolam with Flumazenil group.
Active Comparator: Propofol-based total intravenous anesthesia
Patients 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.
 Drug: Propofol
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patient, age 19-70 years, 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05435911


Contacts
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Contact: Yunseok Jeon, MD, PhD +82-2-2072-2465 jeonyunseok@gmail.com
Contact: Seohee Lee, MD, PhD 82-2-2072-2469 leesen34@gmail.com

Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Yunseok Jeon, MD, PhD Seoul National University Hospital
More Information
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Responsible Party: Yunseok Jeon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT05435911    
Other Study ID Numbers: Remimazolam_recovery
First Posted: June 28, 2022    Key Record Dates
Last Update Posted: August 1, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yunseok Jeon, Seoul National University Hospital:
recovery
remimazolam
flumazenil
propofol
safety
Additional relevant MeSH terms:
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Propofol
Flumazenil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
 Anesthetics
Antidotes
Protective Agents
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action