Patient-controlled sedation vs propofol infusion for ERCP - Patient-controlled sedation for ERCP

• Conditions: ERCP (Endoscopic Retrograde Cholangiopancreatography); MedDRA version: 9.1Level: LLTClassification code 10004676Term: Biliary tract disease; MedDRA version: 9.1Level: LLTClassification code 10004678Term: Biliary tract endoscopy; MedDRA version: 9.1Level: LLTClassification code 10033616Term: Pancreatic disorder; MedDRA version: 9.1Level: LLTClassification code 10053331Term: Pancreatic sphincter operation; MedDRA version: 9.1Level: LLTClassification code 10064858Term: Pancreatic duct dilatation

• Registration Number: EUCTR2008-007968-42-FI
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-23
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Elective ERCP patients
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

under-age, propofol or/and remifentanyl allergy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: procedure performance and complications;Secondary Objective: level of sedation, stability of patient’s vital functions, need of supplemental sedation, recovery time.;Primary end point(s): vital functions:oxygen saturation, end-tidal CO2-concentration measurement, non-invasive automatic blood pressure,continuous electrocardiography;difficulty and the technical performance of the procedure;a patient’s opinion about method;procedural and recovery times;propofol concentrations