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

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ClinicalTrials.gov Identifier: NCT01321047
Recruitment Status : Unknown
Verified March 2011 by Soon Chun Hyang University.
Recruitment status was:  Enrolling by invitation
First Posted : March 23, 2011
Last Update Posted : March 23, 2011
Sponsor:
Information provided by:
Soon Chun Hyang University

Brief Summary:
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 or disease Intervention/treatment Phase
Conscious Sedation Failure During Procedure Drug: Propofol Drug: BPS Phase 4

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  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Balanced Propofol Sedation Versus Propofol Alone Sedation
Study Start Date : April 2011
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

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 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




Primary Outcome Measures :
  1. 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 :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321047


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

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
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: March 23, 2011
Last Verified: March 2011

Keywords provided by Soon Chun Hyang University:
sedation
benzodiazepine
opioid
propofol

Additional relevant MeSH terms:
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics