NCT01072435

Target-controlled Infusion Versus Patient-controlled Sedation With Propofol in Endoscopic Retrograde Cholangiopancreatography (ERCP)

Target-controlled Infusion vs Patient-controlled Sedation With Propofol in ERCP. A Randomized Prospective Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Propofol is a drug of choice for deep sedation in endoscopy. Propofol can be administered in many ways: by infusion or intravenous boluses and with self-administration device (patient-controlled sedation; PCS). It is not clear which method of propofol administration would be preferable. The main objective of the trial is to compare 2 different methods of propofol administration during ERCP: patient-controlled administration(PCS) and target-controlled infusion (TCI).

Detailed description

80 patients of age 18-75 undergoing elective ERCP will be included to the randomized non-commercial clinical trial. Exclusion criteria are: allergy to the opioids or propofol, dementia, mental retardation, severe liver or kidney insufficiency, significant heart failure or lung disease, drug addiction. The endpoints are: ease of procedures performance, complications, degree of sedation, recovery time, propofol and opioid consumption. During the procedure patients observed and treated by the anaesthesiologist and anaesthesia nurse .

Conditions

• Sedation

Interventions

Type	Name	Description
DEVICE	Patient-controlled sedation	Administration of short-acting anesthetic propofol via self-administration device.Single bolus-dose 1ml(10mg)of propofol,lockout time 0sec.,no background infusion or dose-limit.
DEVICE	Target-controlled infusion	Anaesthesiologist´s managed target-controlled infusion of short-acting anesthetic propofol

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-02-22
• Last updated: 2020-12-07

Locations

1 site across 1 country: Finland