Haemodynamic Stability of Ketamine/Propofol Admixture "Ketofol" in Patient Undergoing Endoscopic Retrograde Cholangio Pancreatography

Ketamine

Brief Summary

The investigators aim to evaluate the effect of Ketamine/Propofol Admixture on hemodynamic stability, recovery time ,patient \& doctor satisfaction scores during Endoscopic Retrograde Cholangiopancreatography.

Intervention / Treatment

  • Ketamine / Propofol Admixture (DRUG)
    propofol-ketamine 3:1 mixture(%1 15 ml propofol + 1 ml 50mg/ml ketamine+4 ml saline in a 20-ml syringe which resulted in0.25 mg.ml-1 ketamine and 0.75 mg.ml-1 propofol
  • Propofol (DRUG)
    2 mg/kg I.V

Condition or Disease

  • Pancreatitis
  • Cholangitis

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years to 60 Years
    Enrollment: 90 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jul 01, 2015
    Primary Completion: Jul 01, 2018 ACTUAL
    Completion Date: Sep 01, 2018 ACTUAL
    Study First Posted: Dec 01, 2015 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Sep 20, 2019

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    Location

    Asyut, Egypt

    Participant Groups

    • Ketamine / Propofol Admixture: I.V propofol-ketamine 3:1 mixture(%1 15 ml propofol + 1 ml 50mg/ml ketamine+ 4 ml saline in a 20-ml syringe which resulted in 0.25 mg.ml-1 ketamine and 0.75 mg.ml-1 propofol.

    • I.V propofol 2 mg/kg

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 60
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * American Society of Anesthesiologists ( I ,II )

    Exclusion Criteria:

    1. Presence of liver and/or kidney failure, neuropsychiatric disorders, morbid obesity.
    2. History of substance abuse or dependence.
    3. History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs.
    4. Pregnancy.

    Primary Outcomes
    • mean arterial blood pressure from baseline of patient undergoing Endoscopic Retrograde Cholangio pancreatography every 5 minutes up to 30minutes
    • saturation of oxygen from baseline of undergoing Endoscopic Retrograde Cholangio pancreatography every 5 minutes up to 30 minutes
    • Heart rate( beat/minute) from baseline of patient every 5 minutes up to 30 minutes
    • Recovery score of patient up to 10 minutes after the end of procedure
    Secondary Outcomes
    • patient and doctor satisfaction score through study completion, an average of 1 year

    More Details

    NCT Number: NCT02618668
    Acronym: Assiutu
    Other IDs: Momen01098983009
    Study URL: https://clinicaltrials.gov/study/NCT02618668
    Last updated: Sep 29, 2023