Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01840371
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : June 4, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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 Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Study Start Date : April 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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




Primary Outcome Measures :
  1. Recovery time [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840371


Locations
Layout table for location information
Korea, Republic of
Severance Hospital, Yonsei University
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Publications of Results:
Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01840371     History of Changes
Other Study ID Numbers: 4-2013-0012
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: June 4, 2014
Last Verified: June 2014
Keywords provided by Yonsei University:
ERCP
Sedation
Fentanyl
Propofol
Additional relevant MeSH terms:
Layout table for MeSH terms
Fentanyl
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia