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

NCT01540084 | Completed Phase 4

• 1 other identifier: PA-001
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorders of Gallbladder, Biliary Tract and Pancreas

Keywords

Cocktail sedation; ERCP

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Cardiopulmonary complications

  participants will be followed for the duration of procedure, an expected average of 1.5 hours

Study Arms (2)

conventional group

ACTIVE COMPARATOR

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

cocktail group

EXPERIMENTAL

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

Interventions

propofol DRUG

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.

Also known as: diprivan

cocktail group; conventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for ERCP

You may not qualify if:

• 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

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead

Study Sites (1)

Gastroenterology Unit, King Chulalongkorn Memorial Hospital

Patumwan, Bangkok, 10330, Thailand

Location

Related Publications (1)

• Angsuwatcharakon P, Rerknimitr R, Ridtitid W, Kongkam P, Poonyathawon S, Ponauthai Y, Sumdin S, Kullavanijaya P. Cocktail sedation containing propofol versus conventional sedation for ERCP: a prospective, randomized controlled study. BMC Anesthesiol. 2012 Aug 9;12:20. doi: 10.1186/1471-2253-12-20.

  PMID: 22873637 DERIVED

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Rungsun Rerknimitr, MD

  Gastroenterology unit, King Chulalongkorn Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 28, 2012
• Study Start: December 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

TH (1)