A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy
Status:
Completed
Trial end date:
2004-12-01
Target enrollment:
Participant gender:
Summary
This study was designed to demonstrate that AQUAVAN® is effective in providing adequate
sedation in patients undergoing colonoscopy as well as to assess the safety profile of
AQUAVAN versus that of midazolam. Prior to the procedure, patients received fentanyl citrate
for pain management followed five minutes later by AQUAVAN® Injection for sedation.
Throughout the procedure, study personnel assessed the patient's vital signs and depth of
sedation. After the procedure, the patient, physician, and an evaluator were asked to
complete satisfaction surveys.
Phase:
Phase 3
Details
Lead Sponsor:
Eisai Inc.
Collaborators:
Bio Analytical Research Corporation Coghlan Group (Plasma Sample Supplies) MDS Pharma Services PPD