drugset / Trial / NCT01304342

Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP) With or Without Opioids

NCT01304342 ↗

Completed 180 enrolled University of Athens
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Addition of fentanyl or remifentanil to the propofol produced sedation for scheduled ERCP will decrease the propofol requirements for predetermined sedation levels (as shown by Bispectral Index Monitor (BIS) monitor), will be associated with faster recovery monitored by Ramsay's and Observer's Assessment of Alertness/Sedation (OAAS) scores and BIS, less postoperative pain (assessed by Visual Analogue Scale=VAS) and less early cognitive impairment after sedation (as assessed by the MiniMental test).

Timeline

Start
2011-02
Primary completion
2013-01
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fentanyl Other / unclassified 200 ug Intranasal
Comparator Remifentanil Small molecule 1 ug/kg Intravenous

Indications