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

Ajou University School of Medicine

Status: Not yet enrolling

Conditions: Remimazolam

Treatments: Drug: remifantanil; Drug: Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05434494

AJIRB-MED-INT-22-008

Details and patient eligibility

About

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. .

Enrollment: 80 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No 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.)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

remifentanil group

Active Comparator group

Description:

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.

Treatment:

Drug: remifantanil

Drug: Remimazolam

control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Remimazolam