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

NCT01840371 | Completed

• 1 other identifier: 4-2013-0012
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Retrograde Cholangiopancreatography

Keywords

ERCP; Sedation; Fentanyl; Propofol

Outcome Measures

Primary Outcomes (1)

• Recovery time

  Recovery time (time from scope withdrawal to full recovery)

  time from scope withdrawal to full recovery at averange 24 hours

Secondary Outcomes (1)

• Adverse event during and after procedure

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

Study Arms (2)

Propofol based group

EXPERIMENTAL

Drug: Conventional sedation

Fentanyl based group

ACTIVE COMPARATOR

Drug: Experimental sedation

Interventions

Conventional sedation DRUG

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

Propofol based group

Experimental sedation DRUG

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

Fentanyl based group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients who scheduled for ERCP

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (2)

• Lee TH, Lee CK, Park SH, Lee SH, Chung IK, Choi HJ, Cha SW, Moon JH, Cho YD, Hwangbo Y, Kim SJ. Balanced propofol sedation versus propofol monosedation in therapeutic pancreaticobiliary endoscopic procedures. Dig Dis Sci. 2012 Aug;57(8):2113-21. doi: 10.1007/s10620-012-2234-0. Epub 2012 May 22.

  PMID: 22615018 RESULT

• Angsuwatcharakon P, Rerknimitr R, Ridtitid W, Kongkam P, Poonyathawon S, Ponauthai Y, Sumdin S, Kullavanijaya P. Cocktail sedation containing propofol versus conventional sedation for ERCP: a prospective, randomized controlled study. BMC Anesthesiol. 2012 Aug 9;12:20. doi: 10.1186/1471-2253-12-20.

  PMID: 22873637 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: April 25, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 4, 2014

Record last verified: 2014-06

Locations

KR (1)