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

Not Applicable

• Conditions: Remimazolam
• Interventions: Drug: Remimazolam; Drug: remifantanil

• Registration Number: NCT05434494
• Lead Sponsor: Ajou University School of Medicine

Brief Summary

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. .

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-26
• Last Update Submitted: 2022-06-26
• Study First Posted: 2022-06-28
• Last Update Posted: 2022-06-28
• Study Start: 2022-07-01
• Primary Completion: 2023-07-30
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
remifentanil group	Remimazolam	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.
remifentanil group	remifantanil	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.
control group	Remimazolam	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.

Primary Outcome Measures

Name	Time	Method
Remimazolam dose at which loss of consciousness occurs	3 min after remimazolam injection	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.

Secondary Outcome Measures

Name	Time	Method
Time to loss of consciousness	time after injection of remimazolam to loss of conciousness	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