Clinical trial NCT01321047: Balanced Propofol Sedation Versus Propofol Alone Sedation in Therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official title: Phase 4 Study of Balanced Propofol Sedation Versus Propofol Alone Sedation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Conscious Sedation Failure During Procedure
Keywords: sedation
benzodiazepine
opioid
propofol
Lead sponsor: Soon Chun Hyang University
Sponsor class: OTHER
First posted: 2011-03-23
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Recovery time and cost-effectiveness
timeFrame: SIX MONTH
Secondary outcomes:
measure: Sedation efficacy, procedure-related outcomes, and complications.
timeFrame: SIX MONTH
Other outcomes:
Locations:
Study officials:
affiliation: Soonchunhyang University College of Medicine
name: Tae Hoon Lee, MD
role: STUDY_CHAIR
References: