Balanced Propofol Sedation Versus Propofol Alone Sedation in Therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP) (ERCP)

Phase 4 Study of Balanced Propofol Sedation Versus Propofol Alone Sedation

Based on previous results, the investigators considered that sedation quality, complications, and procedure outcomes may not be different, however, propofol alone titration may have a fast recovery time than BPS and cost-effectiveness than balanced propofol sedation (BPS). In present study, the investigators therefore evaluate the time and sedation quality of patient recovery, cost-effectiveness, complication, and procedure outcomes between propofol alone and BPS in therapeutic endoscopic retrograde cholangiopancreatography (ERCP).

Study Overview

• Status: Unknown
• Conditions: Conscious Sedation Failure During Procedure
• Intervention / Treatment: Drug: Propofol; Drug: BPS

Detailed Description

Previous studies have shown that propofol is superior to traditional sedation regimens with benzodiazepines plus opioids in ERCP procedures. Propofol is a potent hypnotic drug with a short duration of action and consequently a more rapid recovery time for the patients compared with the available Benzodiazepines. Several prospective studies have shown that balanced propofol sedation (BPS) can be used safely and effectively for diagnostic endoscopy under the direction of a gastroenterologist. BPS which was originally described by Cohen et al, combines small incremental doses of propofol with single induction doses of benzodiazepines and opioids under the direction of a physician that is not an anesthesiologist. Because BPS usually targets moderate sedation, adequate amnesia and analgesia can be achieved with concomitant administration of benzodiazepines and opioids. It may cause synergism between propofol and midazolam and reduce dose of propofol. However, there was no proven benefit between propofol alone titrated to moderate level of sedation and BPS; propofol titration combination with benzodiazepines and fentanyl.

• Study Type: Interventional
• Enrollment (Anticipated): 204
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• candidates for therapeutic ERCP

Exclusion Criteria:

• patient age < 18 years
• pregnant women
• inability to provide informed consent
• patients with total gastrectomy
• American Society of Anesthesiologist (ASA) Class V patients
• patients with known respiratory disease, patients with neurologic impairment
• patients with known allergy to the drugs used, history of complications with previous sedation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol group; the conventional propofol group (P group), sedation was induced by an intravenous bolus injection of propofol (0.5 mg/kg body weight; 10 mg if age > 70 or ASA class III-IV).	Drug: Propofol; propofol (0.5 mg/kg body weight; 10 mg if age > 70 or ASA class III-IV); Other Names: A GROUP
Active Comparator: BPS group; the balanced propofol sedation group (BPS group), both midazolam (0.05 mg/kg body weight; 1 mg if age > 70 or ASA class III-IV) and fentanyl (50 µg; 25 µg if age > 70 or ASA class III-IV) were given intravenously at the initiation of sedation. Thereafter, an initial bolus of propofol (0.5 mg/kg body weight) was given intravenously. Sedation was maintained with repeated doses of 10 to 20 mg propofol.	Drug: BPS; midazolam (0.05 mg/kg body weight; 1 mg if age > 70 or ASA class III-IV) fentanyl (50 µg; 25 µg if age > 70 or ASA class III-IV) propofol (0.5 mg/kg body weight); Other Names: B GROUP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery time and cost-effectiveness	Following therapeutic ERCP,full recovery time scoring by Aldrete scoring system and cost measured.	SIX MONTH

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation efficacy, procedure-related outcomes, and complications.	Sedation efficacy parameters was defined as follows; Onset of effective sedation, Patient cooperation (endoscopist, observer-nurse), recovery time, and Patient tolerance (rated by the patients 4hr after procedure). Quality of procedure was assessed by procedure outcomes and procedure related complications.	SIX MONTH

Collaborators and Investigators

• Sponsor: Soon Chun Hyang University
• Investigators: Study Chair: Tae Hoon Lee, MD, Soonchunhyang University College of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): September 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: March 22, 2011
• First Submitted That Met QC Criteria: March 22, 2011
• First Posted (Estimate): March 23, 2011

Study Record Updates

• Last Update Posted (Estimate): March 23, 2011
• Last Update Submitted That Met QC Criteria: March 22, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: opioid; sedation; propofol; benzodiazepine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: SCH-2011-18