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

NCT01840371 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2014-06-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01840371 on ClinicalTrials.gov