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

Phase 4

Completed

• Conditions: Disorders of Gallbladder, Biliary Tract and Pancreas
• Interventions: Drug: propofol

• Registration Number: NCT01540084
• Lead Sponsor: King Chulalongkorn Memorial Hospital

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.

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2009-08
• Study Completion: 2009-12
• Status Verified: 2012-02
• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-27
• Last Update Submitted: 2012-02-27
• Study First Posted: 2012-02-28
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional group	propofol	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.
cocktail group	propofol	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.

Primary Outcome Measures

Name	Time	Method
procedure related time	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 Outcome Measures

Name	Time	Method
Cardiopulmonary complications	participants will be followed for the duration of procedure, an expected average of 1.5 hours	(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.

Trial Locations

Locations (1)

Gastroenterology Unit, King Chulalongkorn Memorial Hospital; 🇹🇭 Patumwan, Bangkok, Thailand