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DRINK: Dose of Remi in Children

Sponsor
Zhihong LU (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05990673
Collaborator
(none)
25
Enrollment
1
Arm
1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Remimazolam has demonstrated the potential as a valuable medication for procedural sedation and general anesthesia. However, the effective dosage of remimazolam in pediatric patients is still unknown.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Determination of the 50% and 95% Effective Dose of Remimazolam for Intravenous Anesthesia Induction in Pediatric Patients
Anticipated Study Start Date :
Aug 10, 2023
Anticipated Primary Completion Date :
Sep 10, 2023
Anticipated Study Completion Date :
Sep 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: remimazolam

remimazolam is given for anesthesia induction

Drug: Remimazolam
remimazolam is given intravenously
Other Names:
  • remimazolam besylate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. half effective dosage [from injection of remimazolam to loss of consciousness, at an average of 5 minutes]

      the dosage by which half of the patients will be sedated

    Secondary Outcome Measures

    1. 95% effective dosage [from injection of remimazolam to loss of consciousness, at an average of 5 minutes]

      the dosage by which 95% of the patients will be sedated

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age from 3 to 12 years old

    • patients scheduled for surgery under general anesthesia

    Exclusion Criteria:

    • American Society of Anesthesiologists status >=Ⅲ

    • Body mass index>=28kg/m2

    • patients who cannot cooperate with intravenous anesthesia induction

    • patients with risk of difficult airway

    • patients who are allergic to benzodiazepines

    • patients with delayed neurologic function

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Zhihong LU

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhihong LU, Associate professor, Air Force Military Medical University, China
    ClinicalTrials.gov Identifier:
    NCT05990673
    Other Study ID Numbers:
    • XJH-A-20230606
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zhihong LU, Associate professor, Air Force Military Medical University, China
    general anesthesia
    anesthesia induction
    remimazolam

    Study Results

    No Results Posted as of Aug 14, 2023