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Dose Finding Study for Remimazolam in Children

Sponsor
Seoul National University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05975255
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
16.6
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to find effective dose of remimazolam for inducing loss of consciousness in children aged 2 to 8 years old. We will explore ED90 of remimazolam for loss of consciousness in 2 minutes after intravenous injection, via a up-and-down method with biased-coin design.

Condition or Disease Intervention/Treatment Phase
  • Drug: Remimazolam besylate
 Phase 2

Detailed Description

We will administer remimazolam intravenously to the study participants. Remimazolam will be infused in 30 seconds to the participants, and we will wait for 2 minutes for the participants be sedated.

When a participant was not sedated in 2 minutes, dose of remimazolam in the next participant will be escalated by 0.05mg/kg. When a participant was sedated in 2 minutes, dose of remimazolam in the next participant will be decreased by 0.05mg/kg or maintained as same. The probability of decrement and maintenance will be 90% and 10% respectively. The dose of remimazolam in the first participant of the study will be 0.05mg/kg.

We will collect the results and obtain ED90 of remimazolam for loss of consciousness in children aged 2 to 8 years old.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Intervention Model Description:
Sequential allocation to drug dosage according to result of previous participantSequential allocation to drug dosage according to result of previous participant
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effective Dose of Remimazolam for Loss of Consciousness in Children: A Prospective Dose Finding Study
Anticipated Study Start Date :
Aug 15, 2023
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study group

Remimazolam administration and evaluation of sedative effect

Drug: Remimazolam besylate
Intravenous administration of predetermined dose of Byfavo for 30 seconds
Other Names:
  • Byfavo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Loss of consciousness [From start of remimazolam administration to 2 minute after end of administration]

      Score 3 or more in the University of Michigan Sedation Scale in less than 2 minutes after administration of remimazolam besylate

    Secondary Outcome Measures

    1. UMSS (University of Michigan Sedation Scale) [From start of remimazolam administration to 2 minute after end of administration]

      Serial measurement of University of Michigan Sedation Scale

    2. Heart rate [From start of remimazolam administration to 2 minute after end of administration]

      Serial measurement of heart rate

    3. Pulse oximetry [From start of remimazolam administration to 2 minute after end of administration]

      Serial measurement of pulse oximetry

    4. Noninvasive mean blood pressure [From start of remimazolam administration to 2 minute after end of administration]

      Serial measurement of noninvasive mean blood pressure

    5. Anesthetic depth [From start of remimazolam administration to 2 minute after end of administration]

      Serial measurement of electroencephalogram-based anesthetic depth monitoring

    6. Apnea [From start of remimazolam administration to 2 minute after end of administration]

      Incidence of apnea after administration of remimazolam besylate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 8 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Children scheduled to undergo general anesthesia or sedation

    • American Society of Anesthesiologist Physical Status of 1 or 2

    Exclusion Criteria:

    • Presence of Upper respiratory tract infection or any pulmonary disease

    • Presence of subglottic stenosis, laryngomalacia, or tracheomalacia

    • History of hypersensitivity to benzodiazepines or propofol

    • History of hypersensitivity to beans or peanut

    • History of seizure

    • Presence of arrhythmia, tachycardia, or bradycardia

    • Presence of acute closed-angle glaucoma

    • Patients with unstable vital sign

    • Presence of sleep apnea

    • Presence of galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption disorder

    • History of hypersensitivity to dextran 40

    • Refusal to enroll by one or more parents or legal guardian

    • Other conditions the researchers regarded as inappropriate to enroll

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 03080

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Jin-Tae Kim, M.D., Ph.D., Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jin-Tae Kim, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT05975255
    Other Study ID Numbers:
    • 2306-198-1445
    First Posted:
    Aug 3, 2023
    Last Update Posted:
    Aug 7, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Jin-Tae Kim, Professor, Seoul National University Hospital
    Remimazolam
    Children
    Dose

    Study Results

    No Results Posted as of Aug 7, 2023