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

Phase 2

Terminated

• Conditions: Pancreatitis; Cholangitis
• Interventions: Drug: Propofol; Drug: Ketamine / Propofol Admixture

• Registration Number: NCT02618668
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-28
• Study First Posted: 2015-12-01
• Primary Completion: 2018-07
• Study Completion: 2018-09
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-20
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	I.V propofol 2 mg/kg
Ketamine / Propofol Admixture	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.

Primary Outcome Measures

Name	Time	Method
Recovery score of patient	up to 10 minutes after the end of procedure
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

Secondary Outcome Measures

Name	Time	Method
patient and doctor satisfaction score	through study completion, an average of 1 year

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, Egypt