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

Remimazolam Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05434494
• Other study ID #: AJIRB-MED-INT-22-008
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: June 2022
• Source: Ajou University School of Medicine
• Contact: ji young yoo
• Phone: 01056902104
• Email: anesyoo[@]aumc.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 31, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Remimazolam
• Unconsciousness

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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