NCT01321047

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

Phase 4 Study of Balanced Propofol Sedation Versus Propofol Alone Sedation

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Soon Chun Hyang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Conscious Sedation Failure During Procedure

Interventions

Type	Name	Description
DRUG	Propofol	propofol (0.5 mg/kg body weight; 10 mg if age \> 70 or ASA class III-IV)
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)

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-09-01
• Completion: 2011-10-01
• First posted: 2011-03-23
• Last updated: 2011-03-23