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

Sponsor

Ajou University School of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05434494

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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. .

Condition or Disease	Intervention/Treatment	Phase
Remimazolam	Drug: Remimazolam Drug: remifantanil	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ajou University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiyoung Yoo, associate professor, Ajou University School of Medicine

ClinicalTrials.gov Identifier:

NCT05434494

Other Study ID Numbers:

AJIRB-MED-INT-22-008

First Posted:

Jun 28, 2022

Last Update Posted:

Jun 28, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Unconsciousness

Study Results

No Results Posted as of Jun 28, 2022