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
  Purpose

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.


Condition Intervention Phase
Disorders of Gallbladder, Biliary Tract and Pancreas
Drug: propofol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cocktail Sedation Containing Propofol Versus Conventional Sedation for ERCP: a Prospective, Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by King Chulalongkorn Memorial Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 205
Study Start Date: December 2006
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540084

Locations
Thailand
Gastroenterology Unit, King Chulalongkorn Memorial Hospital
Patumwan, Bangkok, Thailand, 10330
Sponsors and Collaborators
King Chulalongkorn Memorial Hospital
Investigators
Principal Investigator: Rungsun Rerknimitr, MD Gastroenterology unit, King Chulalongkorn Memorial Hospital
  More Information

No publications provided

Responsible Party: Rapat Pittayanon, MD, Principal investigator, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier: NCT01540084     History of Changes
Other Study ID Numbers: PA-001
Study First Received: February 16, 2012
Last Updated: February 27, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by King Chulalongkorn Memorial Hospital:
Cocktail sedation
ERCP

Additional relevant MeSH terms:
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Propofol
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on July 29, 2014