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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01840371
• Collaborator: (none)
• Enrollment: 220
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 20

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endoscopic Retrograde Cholangiopancreatography	Drug: Conventional sedation; Drug: Experimental sedation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Propofol based group	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
Active Comparator: Fentanyl based group	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital, Yonsei University	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT01840371
• Other Study ID Numbers: 4-2013-0012
• First Posted: Apr 25, 2013
• Last Update Posted: Jun 4, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Yonsei University: ERCP; Sedation; Fentanyl; Propofol

Study Results

No Results Posted as of Jun 4, 2014