Cocktail Sedation Containing Propofol Versus Conventional Sedation for ERCP: a Prospective, Randomized Controlled Study
Overview
- Phase
- Phase 4
- Intervention
- propofol
- Conditions
- Disorders of Gallbladder, Biliary Tract and Pancreas
- Sponsor
- King Chulalongkorn Memorial Hospital
- Enrollment
- 205
- Locations
- 1
- Primary Endpoint
- procedure related time
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
Endoscopic retrograde cholangiopancreatography (ERCP) practically requires moderate to deep sedation by a combination of benzodiazepine and opioid. Propofol as a sole agent may cause oversedation. A combination (cocktail) of infused propofol, meperidine, and midazolam can reduce the dosage of propofol and may result in a lower risk of oversedation. The investigators prospectively compare the efficacy, recovery time, patient satisfactory, and side effects between cocktail and conventional sedations in patients undergoing ERCP.
Detailed Description
ERCP patients were prospectively randomized into 2 groups; the cocktail group and the controls. For induction, a combination of 25 mg of meperidine and 2.5 mg of midazolam were injected in both groups. In the cocktail group, a bolus dose of propofol 1 mg/kg was administered and continuously infused. In the controls, 25 mg of meperidine or 2.5 mg/kg of midazolam were titrated to maintain the level of sedation.
Investigators
Rapat Pittayanon, MD
Principal investigator
King Chulalongkorn Memorial Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients scheduled for ERCP
Exclusion Criteria
- •Age under 18 years
- •American Society of Anesthesiologists' (ASA) physical classification IV - V
- •History of sulfite, egg or soy bean allergy
- •Emergency need for ERCP
- •Informed consent could not be obtained
Arms & Interventions
conventional group
For induction, 25 mg of meperidine and 2.5 mg of midazolam were administered. To maintain conscious level of patient at moderate or deep level, 25 mg of meperidine and/or 2.5 mg of midazolam were administered as necessary.
Intervention: propofol
cocktail group
For induction, 25 mg of meperidine and 2.5 mg of midazolam were administered. To maintain conscious level of patient at moderate or deep level, 1% propofol at the rate of 1 mg/kg/hr was administered. An additional 0.5 mg/kg bolus was administered as needed to achieve the designed conscious level.
Intervention: propofol
Outcomes
Primary Outcomes
procedure related time
Time Frame: participants will be followed for the duration of procedure, an expected average of 1.5 hours
(1) induction time (the time from sedation to scope intubation), (2) procedural time (the time from scope intubation to scope withdrawal), and (3) recovery time (the time from scope withdrawal to full recovery (modified Aldrete score of 10)). The induction time and procedural time were recorded by the nurse in the endoscopy unit.
Secondary Outcomes
- Cardiopulmonary complications(participants will be followed for the duration of procedure, an expected average of 1.5 hours)