Ketamine- Propofol Versus Pethidine- Propofol in ERCP

Sedation in ERCP Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651792
• Other study ID #: ketfol versus pethidine
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2015
• Last updated: April 27, 2016
• Start date: January 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sedation in ERCP

Intervention

Drug:
• ketamine- propofol
1 mg x kg(-1) ketamine + 1.2 mg x kg(-1) propofol.
• pethidine- propofol
1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction

Locations

Country	Name	City	State
Egypt	Al Rajhy liver hospital	Asyut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	amount of propofol consumed during procedure		Immediately after procedure.	Yes
Primary	endoscopist satisfaction using 5 step scale (5= optimal condition; 1= poor condition)		Immediately after procedure.	Yes