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

Sponsor
Assiut University (Other)
Overall Status
Terminated
CT.gov ID
NCT02618668
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
38
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Haemodynamic Stability of Ketamine / Propofol Admixture "Ketofol" in Patient Undergoing Endoscopic Retrograde Cholangio Pancreatography
Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Jul 1, 2018
Actual Study Completion Date :
Sep 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ketamine / Propofol Admixture

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.

Drug: Ketamine / Propofol Admixture
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
Active Comparator: Propofol

I.V propofol 2 mg/kg

Drug: Propofol
2 mg/kg I.V

Outcome Measures

Primary Outcome Measures

  1. mean arterial blood pressure from baseline of patient undergoing Endoscopic Retrograde Cholangio pancreatography [every 5 minutes up to 30minutes]

  2. saturation of oxygen from baseline of undergoing Endoscopic Retrograde Cholangio pancreatography [every 5 minutes up to 30 minutes]

  3. Heart rate( beat/minute) from baseline of patient [every 5 minutes up to 30 minutes]

  4. Recovery score of patient [up to 10 minutes after the end of procedure]

Secondary Outcome Measures

  1. patient and doctor satisfaction score [through study completion, an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut university hospital Assiut Egypt 11111

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Mohamed A Bakr, Prof., Assiut University
  • Study Director: Nagwa m osman, Asst.prof., Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
m mostfa youssef mekky, resident of anesthesia and ICU, Assiut University, Assiut University
ClinicalTrials.gov Identifier:
NCT02618668
Other Study ID Numbers:
  • Momen01098983009
First Posted:
Dec 1, 2015
Last Update Posted:
Sep 23, 2019
Last Verified:
Sep 1, 2019
Additional relevant MeSH terms:
Pancreatitis
Cholangitis
Ketamine
Propofol

Study Results

No Results Posted as of Sep 23, 2019