The Effect of Remifentanil on ED95 of Remimazolam for Loss of Consciousness in Adult Patients
NCT ID: NCT05434494
Last Updated: 2022-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2022-07-01
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.)
19 Years
65 Years
ALL
No
Sponsors
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Ajou University School of Medicine
OTHER
Responsible Party
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Jiyoung Yoo
associate professor
Central Contacts
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Other Identifiers
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AJIRB-MED-INT-22-008
Identifier Type: -
Identifier Source: org_study_id
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