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

NCT ID: NCT02618668

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-09-30

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.

Conditions

Pancreatitis; Cholangitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ketamine / Propofol Admixture

Intervention Type: DRUG

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

I.V propofol 2 mg/kg

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

2 mg/kg I.V

Interventions

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

Intervention Type: DRUG

Propofol

2 mg/kg I.V

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

m mostfa youssef mekky

resident of anesthesia and ICU, Assiut University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed A Bakr, Prof.

Role: STUDY_CHAIR

Assiut University

Nagwa m osman, Asst.prof.

Role: STUDY_DIRECTOR

Assiut University

Locations

Assiut university hospital

Asyut, , Egypt

Countries

Egypt

Other Identifiers

Momen01098983009

Identifier Type: -

Identifier Source: org_study_id