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Cocktail Sedation Containing Propofol Versus Conventional Sedation for Endoscopic Retrograde Cholangiopancreatography (ERCP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01540084
First received: February 16, 2012
Last updated: February 27, 2012
Last verified: February 2012
History of Changes

February 16, 2012
February 27, 2012
December 2006
August 2009   (final data collection date for primary outcome measure)
procedure related time [ Time Frame: participants will be followed for the duration of procedure, an expected average of 1.5 hours ] [ Designated as safety issue: No ]
(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.
Same as current
Complete list of historical versions of study NCT01540084 on ClinicalTrials.gov Archive Site
Cardiopulmonary complications [ Time Frame: participants will be followed for the duration of procedure, an expected average of 1.5 hours ] [ Designated as safety issue: Yes ]
(1) hypotension (systolic blood pressure drops to less than 90 mmHg or decreases more than 25% from the baseline), (2) bradycardia (heart rate <40 beats/min), (3) desaturation (oxygen saturation <90% for >10 seconds), and (4) apnea (cessation of respiratory activity for over 10 seconds under visual observation). If the oxygen saturation dropped to <85% for more than 30 seconds despite oxygen supplementation or apnea occurred, the procedure would be interrupted and reversal medications would be given to the patient.
Same as current
Not Provided
Not Provided
 
Cocktail Sedation Containing Propofol Versus Conventional Sedation for Endoscopic Retrograde Cholangiopancreatography (ERCP)
Cocktail Sedation Containing Propofol Versus Conventional Sedation for ERCP: a Prospective, Randomized Controlled Study

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Disorders of Gallbladder, Biliary Tract and Pancreas
Drug: propofol
For induction, 25 mg of meperidine and 2.5 mg of midazolam were administered in both groups. In the cocktail group, one milligram per kilogram body weight of 1% propofol emulsion (Baxter Healthcare Corp., Irvine, CA) was slowly infused by an automated pump (Terufusion syringe pump TE-331, Terumo Corporation, Tokyo, Japan). To maintain conscious level of patient in the conventional group to be at moderate or deep level, 25 mg of meperidine and/or 2.5 mg of midazolam were administered as necessary, whereas patients in the cocktail group were continuously administered with 1% propofol at the rate of 1 mg/kg/hr. An additional 0.5 mg/kg bolus was administered as needed to achieve the designed conscious level.
Other Name: diprivan
  • Active Comparator: 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: Drug: propofol
  • Experimental: 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: Drug: propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
205
December 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01540084
PA-001
No
Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital
King Chulalongkorn Memorial Hospital
Not Provided
Principal Investigator: Rungsun Rerknimitr, MD Gastroenterology unit, King Chulalongkorn Memorial Hospital
King Chulalongkorn Memorial Hospital
February 2012

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