drugset / Trial / NCT01304342
Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP) With or Without Opioids
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fentanyl | Other / unclassified | 200 ug | Intranasal |
| Comparator | Remifentanil | Small molecule | 1 ug/kg | Intravenous |