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Comparison of Sedative Effect of Dexmedetomidine and Midazolam for TIVA

Sponsor
Sheikh Zayed Medical College (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05574179
Collaborator
(none)
60
Enrollment
2
Arms
10
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Comparison of sedative effects of dexmedetomidine and midazolam using ramsay sedation scores intraoperatively in children undergoing inguinal hernia repair.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

a randomized controlled trial to compare the sesative effects of dexmedetomidine and midazolam in pediatric population planned for inguinal herna repair under TIVA in sheikh zayed hospital rahim yar khan.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Health Services Research
Official Title:
Comparison of Sedative Effect of Dexmedetomidine and Midazolam for TIVA in Pediatric Population Undergoing Inguinal Hernia Repair, Randomized Controlled Trial
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: midazola.

Inj.midazolam

Drug: Midazolam
Inj.midazolam 5mg/5ml given in stat doses
Experimental: Dexnedetomidine

inj.dexmedetomidine

Drug: Dexmedetomidine injection
Inj precedex 200mcg in 1ml given in stat doses
Other Names:
  • Precidex

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dexmedetomidine is better sedative agent than midazolam in pediatric population [25 minutes]

    Secondary Outcome Measures

    1. Midazolam is better sedating agent than dexmedetomidine in pediatric population [25 minutes]

    2. Midazolam and dexmedetomidine are equally good sedating agents in pediatric population [25 minutes]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • ASA I and II Age 6 to 12 years Any gender
    Exclusion Criteria:
    • ASA III and above Age less than 2 years and above 12 years Congenital heart disease Cardiac arrythmias Congenital abnormalities Respiratory disease Endocrine disorders Mental retardation Organ dysfunction Bleeding disorders Physician or family refusal Previous surgeries Allergy to any drug

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sheikh Zayed Medical College

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Barzah Durrani, Dr Barzah durrani, Sheikh Zayed Medical College
    ClinicalTrials.gov Identifier:
    NCT05574179
    Other Study ID Numbers:
    • Sheikh Zayed Medical College
    First Posted:
    Oct 10, 2022
    Last Update Posted:
    Oct 10, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Midazolam
    Dexmedetomidine

    Study Results

    No Results Posted as of Oct 10, 2022