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

Primary Purpose

Pancreatitis, Cholangitis

Status
Terminated
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine / Propofol Admixture
Propofol
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketamine / Propofol Admixture

Propofol

Arm Description

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

Outcomes

Primary Outcome Measures

mean arterial blood pressure from baseline of patient undergoing Endoscopic Retrograde Cholangio pancreatography
saturation of oxygen from baseline of undergoing Endoscopic Retrograde Cholangio pancreatography
Heart rate( beat/minute) from baseline of patient
Recovery score of patient

Secondary Outcome Measures

patient and doctor satisfaction score

Full Information

First Posted
November 16, 2015
Last Updated
September 20, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02618668
Brief Title
Haemodynamic Stability of Ketamine/Propofol Admixture "Ketofol" in Patient Undergoing Endoscopic Retrograde Cholangio Pancreatography
Acronym
Assiutu
Official Title
Haemodynamic Stability of Ketamine / Propofol Admixture "Ketofol" in Patient Undergoing Endoscopic Retrograde Cholangio Pancreatography
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Cholangitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine / Propofol Admixture
Arm Type
Experimental
Arm Description
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.
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
I.V propofol 2 mg/kg
Intervention Type
Drug
Intervention Name(s)
Ketamine / Propofol Admixture
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
2 mg/kg I.V
Primary Outcome Measure Information:
Title
mean arterial blood pressure from baseline of patient undergoing Endoscopic Retrograde Cholangio pancreatography
Time Frame
every 5 minutes up to 30minutes
Title
saturation of oxygen from baseline of undergoing Endoscopic Retrograde Cholangio pancreatography
Time Frame
every 5 minutes up to 30 minutes
Title
Heart rate( beat/minute) from baseline of patient
Time Frame
every 5 minutes up to 30 minutes
Title
Recovery score of patient
Time Frame
up to 10 minutes after the end of procedure
Secondary Outcome Measure Information:
Title
patient and doctor satisfaction score
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists ( I ,II ) Exclusion Criteria: Presence of liver and/or kidney failure, neuropsychiatric disorders, morbid obesity. History of substance abuse or dependence. History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs. Pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A Bakr, Prof.
Organizational Affiliation
Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nagwa m osman, Asst.prof.
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut university hospital
City
Assiut
ZIP/Postal Code
11111
Country
Egypt

12. IPD Sharing Statement

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

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