Patient-controlled Sedation vs Propofol Infusion for ERCP:a Randomized Controlled Study

NCT01079312 Phase 4 COMPLETED

Background: Deep sedation with propofol and opioid is commonly used for endoscopic retrograde cholangiopancreatography (ERCP), but is associated with increased morbidity and mortality. Delivery of propofol and short-acting potent opioid analgesic using a self-administration device (patient-controlled sedation, PCS) could be another option for this purpose. Comparative studies with PCS for ERCP are lacking.The main objective of this prospective randomized trial trial was to compare PCS with propofol/remifentanil to anaesthesiologist managed propofol sedation during ERCP.

Details

Lead sponsor	Helsinki University Central Hospital
Phase	Phase 4
Status	COMPLETED
Enrolment	80
Start date	2009-01
Completion	2009-04

Conditions

• Endoscopic Retrograde Cholangiopancreatography

Interventions

• infusion pump
• infusion pump for patient-controlled sedation
• propofol
• fentanyl
• sedative mixture
• remifentanil hydrochlorid

Primary outcomes

• propofol and opioid consumption — one day
  total consumption of propofol,milligramms and opioid,microgramms during ERCP procedure
• vital signs — one day
  heart rate,blood pressure,peripheral oxygen saturatuion,breathing rate,expiratory carbon dioxide concentration
• patient´s and endoscopist´s satisfaction — one day
  Likert scale 1-7

Countries

Finland