NCT01840371

Randomized Controlled Study for Analyzing Clinical Benefit of Pain Focused Sedation With Combination of Fentanyl and Propofol During Endoscopic Retrograde Cholangiopancreatography (ERCP)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The investigators study is the randomized controlled study for analyzing clinical benefit of pain focused sedation with combination of fentanyl and propofol during Endoscopic retrograde cholangiopancreatography (ERCP). The investigators will assess recovery time and adverse effect during ERCP as the primary end point between two group. The investigators will also access satisfaction score for endoscopist and patients as the secondary end point.

Conditions

• Endoscopic Retrograde Cholangiopancreatography

Interventions

Type	Name	Description
DRUG	Conventional sedation	Propofol Meperidine : 25 mg IV just before procedure * IV bolus of 1 mg/kg for sedation induction, * Infusion of 60 mcg/min/kg for maintenance of sedation * Additional bolus dose of 10mg as needed for adequate sedation
DRUG	Experimental sedation	Fentanyl * IV bolus of 1 µg/kg for sedation induction * Additional bolus dose of 0.5 µg/kg as needed for adequate pain control Propofol * IV bolus of 0.4 mg/kg for sedation induction * Infusion of 30 µg/min/kg for maintenance of sedation * Additional bolus dose of 10mg as needed for adequate depth of sedation

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-04-25
• Last updated: 2014-06-04

Locations

1 site across 1 country: South Korea