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

NCT05434494 | Unknown

• 1 other identifier: AJIRB-MED-INT-22-008
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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. .

Conditions

Remimazolam

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to loss of consciousness

  time after injection of remimazolam to loss of conciousness

Study Arms (2)

remifentanil group

ACTIVE COMPARATOR

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; Drug: remifantanil

control group

PLACEBO COMPARATOR

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

Interventions

Remimazolam DRUG

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.

control group; remifentanil group

remifantanil DRUG

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.

remifentanil group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Ajou University School of Medicine: lead

MeSH Terms

Interventions

remimazolam

Central Study Contacts

ji young yoo

CONTACT

01056902104; anesyoo@aumc.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 28, 2022
• Study Start: July 1, 2022
• Primary Completion: July 30, 2023
• Study Completion: August 31, 2023
• Last Updated: June 28, 2022

Record last verified: 2022-06