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

Pancreatitis Clinical Trial

— Assiutu  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02618668
• Other study ID #: Momen01098983009
• Status: Terminated
• Phase: Phase 2
• Start date: July 2015
• Est. completion date: September 2018

Study information

• Verified date: September 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: September 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangitis
• Pancreatitis

Intervention

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
• Propofol
2 mg/kg I.V

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

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