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

Phase 4 Completed 80 enrolled Helsinki University Central Hospital

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2009-01
Primary completion: 2009-04
Completion: 2009-04

Publications

Results Mazanikov M, Udd M, Kylanpaa L, Lindstrom O, Aho P, Halttunen J, Farkkila M, Poyhia R. Patient-controlled sedation with propofol and remifentanil for ERCP: a randomized, controlled study. Gastrointest Endosc. 2011 Feb;73(2):260-6. doi: 10.1016/j.gie.2010.10.005.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Propofol	Small molecule	0.5 mg/kg	Intravenous
Comparator	Propofol	Small molecule	9 mg/kg	Intravenous
Comparator	Propofol	Small molecule	20 mg	Intravenous
Comparator	Propofol	Small molecule	40 mg	Intravenous
Comparator	Remifentanil	Small molecule	—	—
Comparator	Fentanyl	Other / unclassified	0.05 mg	Intravenous

Indications

No indication recorded.