Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Soon Chun Hyang University.
Recruitment status was:  Enrolling by invitation
Information provided by:
Soon Chun Hyang University Identifier:
First received: March 22, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Balanced Propofol Sedation Versus Propofol Alone Sedation

Resource links provided by NLM:

Further study details as provided by Soon Chun Hyang University:

Primary Outcome Measures:
  • Recovery time and cost-effectiveness [ Time Frame: SIX MONTH ]
    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 ]

    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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01321047

Sponsors and Collaborators
Soon Chun Hyang University
Study Chair: Tae Hoon Lee, MD Soonchunhyang University College of Medicine
  More Information

Responsible Party: Tae Hoon Lee, Soonchunhyang University College of Medicine, Cheonan Hospital Identifier: NCT01321047     History of Changes
Other Study ID Numbers: SCH-2011-18
Study First Received: March 22, 2011
Last Updated: March 22, 2011

Keywords provided by Soon Chun Hyang University:

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics processed this record on April 28, 2017