Balanced Propofol Sedation Versus Propofol Alone Sedation in Therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP) - Full Text View

Purpose

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).

Condition	Intervention	Phase
Conscious Sedation Failure During Procedure	Drug: Propofol Drug: BPS	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Phase 4 Study of Balanced Propofol Sedation Versus Propofol Alone Sedation

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy

Drug Information available for: Propofol

U.S. FDA Resources

Further study details as provided by Soon Chun Hyang University:

Primary Outcome Measures:

Recovery time and cost-effectiveness [ Time Frame: SIX MONTH ] [ Designated as safety issue: Yes ]
Following therapeutic ERCP,full recovery time scoring by Aldrete scoring system and cost measured.

Secondary Outcome Measures:

Sedation efficacy, procedure-related outcomes, and complications. [ Time Frame: SIX MONTH ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	204
Study Start Date:	April 2011
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: B GROUP

Arms

Assigned Interventions

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 Name: 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 Name: B GROUP

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321047

Sponsors and Collaborators

Soon Chun Hyang University

Investigators

Study Chair:

Tae Hoon Lee, MD

Soonchunhyang University College of Medicine

More Information

No publications provided

Responsible Party:	Tae Hoon Lee, Soonchunhyang University College of Medicine, Cheonan Hospital
ClinicalTrials.gov Identifier:	NCT01321047 History of Changes
Other Study ID Numbers:	SCH-2011-18
Study First Received:	March 22, 2011
Last Updated:	March 22, 2011
Health Authority:	Korea: Institutional Review Board

Keywords provided by Soon Chun Hyang University:

sedation
benzodiazepine
opioid
propofol

Additional relevant MeSH terms:

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 May 21, 2013