Balanced Propofol Sedation Versus Propofol Alone Sedation in Therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP) (ERCP)
|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
|Condition or disease||Intervention/treatment||Phase|
|Conscious Sedation Failure During Procedure||Drug: Propofol Drug: BPS||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||204 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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).
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.
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
- Recovery time and cost-effectiveness [ Time Frame: SIX MONTH ]Following therapeutic ERCP,full recovery time scoring by Aldrete scoring system and cost measured.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321047
|Study Chair:||Tae Hoon Lee, MD||Soonchunhyang University College of Medicine|