The Effect of Remifentanil on ED95 of Remimazolam for Loss of Consciousness in Adult Patients

This study prospectively uses the biased coin technique to investigate the effect of concomitant administration of remifentanil on the 95% effective dose of intravenous remimazolam (Effective dose 95 [ED95]) required for loss of consciousness during anesthesia induction. .

Study Overview

• Status: Not yet recruiting
• Conditions: Remimazolam
• Intervention / Treatment: Drug: Remimazolam; Drug: remifantanil

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The adult patients who are scheduled to surgery under general anesthesia

Exclusion Criteria:

• Severe obesity (BMI > 30 kg/m2)
• Allergy to remimazolam or remifentanil
• Under conditions which make it difficult to respond to the investigator's verbal commends like hearing impairment, etc.
• Patients with general conditions are more than ASA class III
• Patients with brain disease (dementia, cerebral infarction, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: remifentanil group; Start the continuous infusion of 25cc of remifantanil (labeled as a test drug) by TCI mode ( the target effect site concentration is 2.0). While slowly injecting the prescribed dose of remimazolam over 30 seconds, observe whether it responds to the investigator's oral commands and the disappearance of the eyelash reflex for 3 minutes after administering the drug. Success in inducing loss of consciousness during anesthesia is defined as the loss of both verbal command response and eyelash reflex within 3 minutes after infusion, otherwise it is considered a failure. The dose of remimazolam is initially 0.15 mg/kg and the next experimental dose is determined according to the biased coin design up-and-down sequential method. The standard deviation of this study is 0.05 mg.	Drug: Remimazolam; Remimazolam is injected for 30 seconds and the experimental dose will be determined according to the biased coin design up-and-down sequential method. If loss of consciousness is successful, the dose of the next intravenous dose of the next study subject will be reduced from the previous dose with a probability of 1/19 or the same as the previous dose with a probability of 18/19.; Drug: remifantanil; 25cc infusion drug will be prepared (labeled as test drug) and infused with TCI mode. The target effect site concentration is 2.0 ng/ml.
PLACEBO_COMPARATOR: control group; Start the continuous infusion of 25cc of normal saline (labeled as a test drug). While slowly injecting the prescribed dose of remimazolam over 30 seconds, observe whether it responds to the investigator's oral commands and the disappearance of the eyelash reflex for 3 minutes after administering the drug. Success in inducing loss of consciousness during anesthesia is defined as the loss of both verbal command response and eyelash reflex within 3 minutes after infusion, otherwise it is considered a failure. The dose of remimazolam is initially 0.15 mg/kg and the next experimental dose is determined according to the biased coin design up-and-down sequential method. The standard deviation of this study is 0.05 mg.	Drug: Remimazolam; Remimazolam is injected for 30 seconds and the experimental dose will be determined according to the biased coin design up-and-down sequential method. If loss of consciousness is successful, the dose of the next intravenous dose of the next study subject will be reduced from the previous dose with a probability of 1/19 or the same as the previous dose with a probability of 18/19.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remimazolam dose at which loss of consciousness occurs	While slowly injecting the prescribed dose of remimazolam over 30 seconds, observe whether it responds to the investigator's oral commands and the disappearance of the eyelash reflex for 3 minutes after administering the drug. Success in inducing loss of consciousness during anesthesia is defined as the loss of both verbal command response and eyelash reflex within 3 minutes after infusion, otherwise it is considered a failure.	3 min after remimazolam injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to loss of consciousness	After injection of remimazolam, the investigator concludes the successful loss of consciousness (not respond to oral commands and the disappearance of the eyelash reflex); From remimazolam injection until loss of consciousness occurs	time after injection of remimazolam to loss of conciousness

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2022
• Primary Completion (ANTICIPATED): July 30, 2023
• Study Completion (ANTICIPATED): August 31, 2023

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 26, 2022
• First Posted (ACTUAL): June 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 26, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Consciousness Disorders; Unconsciousness
• Other Study ID Numbers: AJIRB-MED-INT-22-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No