ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During 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: NCT01900938
Recruitment Status : Unknown
Verified July 2013 by Kyo-Sang Yoo, Hanyang University.
Recruitment status was:  Not yet recruiting
First Posted : July 17, 2013
Last Update Posted : July 17, 2013
Sponsor:
Information provided by (Responsible Party):
Kyo-Sang Yoo, Hanyang University

May 29, 2013
July 17, 2013
July 17, 2013
September 2013
May 2014   (Final data collection date for primary outcome measure)
Satisfaction scores by endoscopist [ Time Frame: 30 minutes after the procedure ]
Same as current
No Changes Posted
  • Adverse events for sedation [ Time Frame: 1 day after the procedure ]
  • Difficulty scores of maintaining the sedation [ Time Frame: 30 minutes after the procedure ]
Same as current
Not Provided
Not Provided
 
Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During ERCP
Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During Endoscopic Retrograde Cholangiopancreatography: a Prospective Randomized Controlled Study
The aim of this study is to compare sedation efficiency, safety and satisfaction by both endoscopist, assistants, and the patients between continuous infusion and intermittent bolus injection of propofol for deep sedation during ERCP.
The patients undergone ERCP were randomly assigned to either continuous infusion of propofol (continuous group) or midazolam plus intermittent bolus injection of propofol (intermittent group) for deep sedation. In the continuous group, propofol was continuously administered via infusion pump and the doses were determined by sedation assistants monitoring the patients. In the intermittent group, a loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol was initially injected and repeated bolus injection of 20 mg of propofol was followed according to patients' sedation level. Sedation related parameters (total dose of propofol, induction/recovery time, patients' cooperation) and adverse events during the procedure were evaluated. Satisfaction scores by endoscopist, assistant, and patients and difficulty scores of maintaining the sedation by assistants were also graded after the procedure.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Biliary Tract Diseases
  • Pancreatic Diseases
  • Procedure: Continuous infusion of propofol
    Propofol is continuously administered intravenously via infusion pump starting with 20 mg/kg/hr and then titrated to about 5 mg/kg/hr according to patients' sedation level.
  • Procedure: Intermittent bolus injection of propofol
    A loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol is initially injected and then repeated intermittent bolus injection of 20 mg of propofol is followed according to patients' sedation level.
  • Drug: Midazolam
  • Drug: Propofol
  • Active Comparator: Intermittent bolus injection of propofol
    A loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol is initially injected and then repeated intermittent bolus injection of 20 mg of propofol is followed according to patients' sedation level.
    Interventions:
    • Procedure: Intermittent bolus injection of propofol
    • Drug: Midazolam
    • Drug: Propofol
  • Active Comparator: Continuous infusion of propofol
    Propofol is continuously administered intravenously via infusion pump starting with 20 mg/kg/hr and then titrated to about 5 mg/kg/hr according to patients' sedation level.
    Interventions:
    • Procedure: Continuous infusion of propofol
    • Drug: Propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
210
Same as current
May 2014
May 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergone ERCP for biliary and pancreatic diseases

Exclusion Criteria:

  • Comorbid conditions of ASA class 4-5
  • Age under 18 years or over 90 years
  • Pregnancy
  • Past medication history of benzodiazepine or narcotics
  • Known allergy to midazolam or propofol
  • hypotension (systolic blood pressure <90 mmHg), hypoxemia (SaO2 <90%), or bradycardia (50/min) at baseline measurements
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01900938
2012-055
Yes
Not Provided
Not Provided
Kyo-Sang Yoo, Hanyang University
Hanyang University
Not Provided
Principal Investigator: Kyo-Sang Yoo Hanyang University
Hanyang University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP