Ketamine- Propofol Versus Pethidine- Propofol in ERCP

Phase 2

Completed

• Conditions: Sedation in ERCP
• Interventions: Drug: ketamine- propofol; Drug: pethidine- propofol

• Registration Number: NCT02651792
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-11-29
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-11
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketamine- propofol	ketamine- propofol	IV Ketamine 1mg/kg + Propofol 1.2 mg/kg will be given for sedation.
pethidine- propofol	pethidine- propofol	1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction

Primary Outcome Measures

Name	Time	Method
endoscopist satisfaction using 5 step scale (5= optimal condition; 1= poor condition)	Immediately after procedure.

Trial Locations

Locations (1)

Al Rajhy liver hospital; 🇪🇬 Asyut, Egypt