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

Yonsei University

Status: Completed

Conditions: Endoscopic Retrograde Cholangiopancreatography

Treatments: Drug: Experimental sedation; Drug: Conventional sedation

Study type: Interventional

Funder types: Other

Identifiers

NCT01840371

4-2013-0012

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patients who scheduled for ERCP

Exclusion criteria

• The patients with ASA physical classification V
• The patients with history of sulfite, egg or soy bean allergy
• The patients during pregnancy or latency period
• The patients who informed consent could not be obtained
• The patients who were under 20 years old

Trial design

220 participants in 2 patient groups

Propofol based group

Experimental group

Treatment:

Drug: Conventional sedation

Fentanyl based group

Active Comparator group

Treatment:

Drug: Experimental sedation