Remimazolam
Conditions
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. .
Interventions
DRUGRemimazolam
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.
DRUGremifantanil
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.
Sponsors
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary Contactji young yoo
Outcome results
None listed