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

Disorders of Gallbladder, Biliary Tract and Pancreas Clinical Trial

Official title:

Cocktail Sedation Containing Propofol Versus Conventional Sedation for ERCP: a Prospective, Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540084
• Other study ID #: PA-001
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2012
• Last updated: February 27, 2012
• Start date: December 2006
• Est. completion date: December 2009

Study information

• Verified date: February 2012
• Source: King Chulalongkorn Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disorders of Gallbladder, Biliary Tract and Pancreas
• Gallbladder Diseases

Intervention

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.

Locations

Country	Name	City	State
Thailand	Gastroenterology Unit, King Chulalongkorn Memorial Hospital	Patumwan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	procedure related time	(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.	participants will be followed for the duration of procedure, an expected average of 1.5 hours	No
Secondary	Cardiopulmonary complications	(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.	participants will be followed for the duration of procedure, an expected average of 1.5 hours	Yes