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

Not Applicable

Completed

• Conditions: Endoscopic Retrograde Cholangiopancreatography
• Interventions: Drug: Experimental sedation; Drug: Conventional sedation

• Registration Number: NCT01840371
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-22
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-25
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-02
• Last Update Posted: 2014-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• The patients who scheduled for ERCP

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl based group	Experimental sedation	-
Propofol based group	Conventional sedation	-

Primary Outcome Measures

Name	Time	Method
Recovery time	time from scope withdrawal to full recovery at averange 24 hours	Recovery time (time from scope withdrawal to full recovery)

Secondary Outcome Measures

Name	Time	Method
Adverse event during and after procedure	measurements of recovery time during ERCP procedure & after ERCP procedure at average 24 hours	Adverse event during and after procedure i. Desaturation rate ii. Apnea

Trial Locations

Locations (1)

Severance Hospital, Yonsei University; 🇰🇷 Seoul, Korea, Republic of