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Trial record 3 of 95 for:    remimazolam

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

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ClinicalTrials.gov Identifier: NCT05434494
Recruitment Status : Not yet recruiting
First Posted : June 28, 2022
Last Update Posted : June 28, 2022
Sponsor:
Information provided by (Responsible Party):
Jiyoung Yoo, Ajou University School of Medicine

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : July 30, 2023
Estimated Study Completion Date : August 31, 2023

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.





Primary Outcome Measures :
  1. Remimazolam dose at which loss of consciousness occurs [ Time Frame: 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 :
  1. Time to loss of consciousness [ Time Frame: 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



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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05434494


Contacts
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Contact: ji young yoo 01056902104 anesyoo@aumc.ac.kr

Sponsors and Collaborators
Ajou University School of Medicine
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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: June 28, 2022    Key Record Dates
Last Update Posted: June 28, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases