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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01840371

Enrollment

220

Registered

2013-04-25

Start date

2013-04-30

Completion date

2014-03-31

Last updated

2014-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic Retrograde Cholangiopancreatography

Keywords

ERCP, Sedation, Fentanyl, Propofol

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.

Interventions

DRUGConventional 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

DRUGExperimental 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Recovery time	time from scope withdrawal to full recovery at averange 24 hours	Recovery time (time from scope withdrawal to full recovery)

Secondary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026