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Ketamine- Propofol Versus Pethidine- Propofol in ERCP

Ketamine-propofol Versus Pethidine-propofol for Sedating Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02651792
Enrollment
50
Registered
2016-01-11
Start date
2015-01-31
Completion date
2016-04-30
Last updated
2016-04-29

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

Conditions

Sedation in ERCP

Keywords

ketamine, propofol, pethidine, ERCP, endoscopist

Brief summary

The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction.

Detailed description

The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction, amount of propofol consumption Any desaturation or apnea will be recorded when the oxygen saturation (SpO2) dropped to \<90% , time for recovery ,post-operative nausea and vomiting, hallucinations and Ramsey sedation scores of all patients will be recorded perioperatively. The Aldrete score was used to measure recovery from anesthesia at 5 and 10 min after the procedure.

Interventions

DRUGketamine- propofol

1 mg x kg(-1) ketamine + 1.2 mg x kg(-1) propofol.

DRUGpethidine- propofol

1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* both gender * age between 18-70

Exclusion criteria

* pregnant patients. * morbid obesity. * chronic obstructive pulmonary disease. * complicated airway. * American society of anesthesia (ASA) physical classification IV-V. * history of allergy or contraindications to the drugs used in the study * emergency need for ERCP. * those whose informed consent could not be signed. * those with possible complex ERCP.

Design outcomes

Primary

MeasureTime frame
endoscopist satisfaction using 5 step scale (5= optimal condition; 1= poor condition)Immediately after procedure.

Other

MeasureTime frame
amount of propofol consumed during procedureImmediately after procedure.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026