Clinical Trial: Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During ERCP

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During Endoscopic Retrograde Cholangiopancreatography: a Prospective Randomized Controlled Study

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Hanyang University

Current Primary Outcome: Satisfaction scores by endoscopist [ Time Frame: 30 minutes after the procedure ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse events for sedation [ Time Frame: 1 day after the procedure ]
  • Difficulty scores of maintaining the sedation [ Time Frame: 30 minutes after the procedure ]


Original Secondary Outcome: Same as current

Information By: Hanyang University

Dates:
Date Received: May 29, 2013
Date Started: September 2013
Date Completion: May 2014
Last Updated: July 16, 2013
Last Verified: July 2013