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Patient-controlled Sedation With Propofol and Remifentanyl for Endoscopic Retrograde Cholangiopancreatography (ERCP)

Endoscopic Retrograde Cholangiopancreatography Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

80 elective ERCP patients were randomized to anaesthesiologist managed propofol sedation (PI-group) or PCS with propofol/remifentanil (PCS-group). Sedation degree was estimated every 5 min throughout the procedure using Ramsay´s and Gillham´s sedation scores. Total amount of propofol was calculated at the end of procedure. Endoscopists´ and patients´ satisfaction was evaluated with questionary. ;

Study Design

Related Conditions & MeSH terms

  • Endoscopic Retrograde Cholangiopancreatography
Clinical Trial Details
NCT number NCT01079312
Study type Interventional
Source Helsinki University Central Hospital
Contact
Status Completed
Phase Phase 4
Start date January 2009
Completion date April 2009
View Details
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