drugset / Trial / NCT00209586
A Study of AQUAVAN® Injection for Sedation in Elderly Patients Undergoing Flexible Bronchoscopy
Phase 3
Terminated
55 enrolled
Eisai Inc.
Covance · collabPPD Development, LP · collabQuest Pharmaceutical Services · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study was designed to demonstrate that AQUAVAN® is effective in providing adequate sedation in patients undergoing flexible bronchoscopy as well as to assess the safety profile of AQUAVAN versus that of midazolam. Prior to the procedure, patients receive fentanyl citrate for pain management followed five minutes later by either AQUAVAN® Injection or midazolam HCl for sedation. During the procedure, study personnel assess the patient's vital signs and depth of sedation. After the procedure, the patient, physician, and an evaluator are asked to complete satisfaction surveys.
Timeline
- Start
- 2004-09
- Primary completion
- 2005-03
- Completion
- 2005-03
Outcome
Outcome not reported
Stopped (Enrollment): “Patient enrollment was stopped prior to completion of the study in order to re-evaluate the dosing regimen.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | fospropofol | Small molecule | — | Intravenous |