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

Yonsei University220 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

220

Conditions

Endoscopic Retrograde Cholangiopancreatography

Interventions

Conventional sedationDRUG

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

Experimental sedationDRUG

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Recovery time

Recovery time (time from scope withdrawal to full recovery)

Time frame: time from scope withdrawal to full recovery at averange 24 hours

Secondary Outcomes

Adverse event during and after procedure

Adverse event during and after procedure i. Desaturation rate ii. Apnea

Time frame: measurements of recovery time during ERCP procedure & after ERCP procedure at average 24 hours