drugset / Trial / NCT01321047

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

NCT01321047

Phase 4 Unknown 204 enrolled Soon Chun Hyang University
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2011-04
Primary completion
2011-09
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Fentanyl Other / unclassified 25 ug Intravenous
Subject Fentanyl Other / unclassified 50 ug Intravenous
Subject Midazolam Small molecule 0.05 mg/kg Intravenous
Subject Midazolam Small molecule 1 mg Intravenous
Comparator Propofol Small molecule 0.5 mg/kg Intravenous
Comparator Propofol Small molecule 10 mg Intravenous

Indications

No indication recorded.