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

A

Assiut University

Status and phase

Terminated
Phase 2

Conditions

Cholangitis
Pancreatitis

Treatments

Drug: Ketamine / Propofol Admixture
Drug: Propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT02618668
Momen01098983009

Details and patient eligibility

About

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

Enrollment

90 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 2 patient groups

Ketamine / Propofol Admixture
Experimental group
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.
Treatment:
Drug: Ketamine / Propofol Admixture
Propofol
Active Comparator group
Description:
I.V propofol 2 mg/kg
Treatment:
Drug: Propofol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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