NCT01079312

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Endoscopic Retrograde Cholangiopancreatography

Interventions

Type	Name	Description
DEVICE	infusion pump	anaesthesiologist´s managed infusion of propofol 10 mg/ml at rate of 10-60ml/h during ERCP targeting to moderate sedation level
DEVICE	infusion pump for patient-controlled sedation	self-administration of propofol and remifentanil mixture with zero lockout time and without dose limit and background infusion via Arcomed,Syramed AG,Switzerland self-administration pump.
DRUG	propofol	Propofol 10 mg/ml solution is a short-acting, intravenously administered hypnotic agent.In propofol infusion group moderate sedation was initiated with propofol 40 mg bolus,thereafter propofol infusion was started at rate of 0.5 mg/kg/h.If the performance of ERCP become difficult infusion rate was increased gradually ad maximum rate of 9 mg/kg/h.Additional propofol boluses of 20-40 mg were available in both groups due to an anaesthesiollogist´s ´desigion.In patient-controlled sedation group propofol was used for preparation of sedative mixture.
DRUG	fentanyl	Fentanyl citrate 50 mcg/ml,solution for injection,is a narcotic analgesic.In propofol infusion group 0.05 mg of fentanyl was administered intravenously before initiation of sedation. Additional 0.05 mg boluses of fentanyl were given if nociceptive stimulus was anticipated.
DRUG	sedative mixture	Sedative mixture was prepared by adding 5 ml of remifentanil hydrochlorid solution (50 mcg/ml)to 20 ml of propofol (10 mg/ml)
DRUG	remifentanil hydrochlorid	Solution of remifentanil hydrochlorid (50 mcg/ml) was used for preparation of sedative mixture(see sedative mixture for details)

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2010-03-03
• Last updated: 2020-12-22

Locations

1 site across 1 country: Finland