Sedation for Upper Gastrointestinal Endoscopy in Pediatric Patients

Ketamine

Brief Summary

The purpose of this study is to compere between Propofol-Ketamine combination and Dexmedetomidine-Ketamine combination for sedation in upper gastrointestinal endoscopy in paediatric patients.

Intervention / Treatment

  • Dexmedetomidine-ketamine (DRUG)
    N/A
  • Propofol-Ketamine (DRUG)
    N/A

Condition or Disease

  • Upper Gastrointestinal Endoscopy

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 2 Years to 7 Years
    Enrollment: 120 (ACTUAL)
    Funded by: Other
    Allocation: Randomized

    Masking

    DOUBLE:
    • Participant
    • Care Provider

    Clinical Trial Dates

    Start date: Sep 01, 2016
    Primary Completion: Dec 01, 2016 ACTUAL
    Completion Date: Aug 31, 2020
    Study First Posted: Aug 11, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Dec 21, 2016

    Sponsors / Collaborators

    Lead Sponsor: Ain Shams University
    Responsible Party: N/A

    Location

    Cairo, Egypt

    Participant Groups

    • Propofol-Ketamine group: patients in this group will receive IV ketamine at a dose of 1mg.kg-1 in addition to IV propofol 1mg.kg-1 for induction with added doses of propofol 1mg.kg-1 when needed.

    • Dexmedetomidine-Ketamine group: patients in this group will receive IV ketamine at a dose of 1mg.kg-1 in addition to IV dexmedetomidine 0.5 mcg.kg-1 for induction with additional doses of dexmedetomidine 0.5mcg.kg-1 when required

    Eligibility Criteria

    Sex: All
    Minimum Age: 2
    Maximum Age: 7
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * American Society of Anesthesiologists ASA I-II patients aging 2-7 years.

    Exclusion Criteria:

    known allergy to any of the study drugs, significant cardiovascular disease vomiting.

    Primary Outcomes
    • length of stay in PACU three months

    More Details

    NCT Number: NCT02863861
    Other IDs: FMASU R 12/2016
    Study URL: https://clinicaltrials.gov/study/NCT02863861
    Last updated: Sep 29, 2023