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

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

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

Study Overview

• Status: Terminated
• Conditions: Pancreatitis; Cholangitis
• Intervention / Treatment: Drug: Ketamine / Propofol Admixture; Drug: Propofol

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 11111
    • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
patient and doctor satisfaction score	through study completion, an average of 1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: November 16, 2015
• First Submitted That Met QC Criteria: November 28, 2015
• First Posted (Estimate): December 1, 2015

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Pancreatic Diseases; Bile Duct Diseases; Pancreatitis; Cholangitis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Hypnotics and Sedatives; Ketamine; Propofol
• Other Study ID Numbers: Momen01098983009