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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02618668
Acronym
Assiutu
Enrollment
90
Registered
2015-12-01
Start date
2015-07-31
Completion date
2018-09-30
Last updated
2019-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangitis, Pancreatitis

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.

Interventions

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

DRUGPropofol

2 mg/kg I.V

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
mean arterial blood pressure from baseline of patient undergoing Endoscopic Retrograde Cholangio pancreatographyevery 5 minutes up to 30minutes
saturation of oxygen from baseline of undergoing Endoscopic Retrograde Cholangio pancreatographyevery 5 minutes up to 30 minutes
Heart rate( beat/minute) from baseline of patientevery 5 minutes up to 30 minutes
Recovery score of patientup to 10 minutes after the end of procedure

Secondary

MeasureTime frame
patient and doctor satisfaction scorethrough study completion, an average of 1 year

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026