Study of AQUAVAN® Injection (AQUAVAN; Fospropofol Disodium) for Sedation During Colonoscopy
Summary
Very often, patients receive sedative medication before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. During procedural (mild to moderate) sedation, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep him/her calm (sedative). Propofol is the drug commonly used for sedation because it releases immediately into the blood stream and causes fast sedation. AQUAVAN (fospropofol disodium) is made as a slow release version of propofol, allowing for fast sedation and possibly faster recovery and discharge. This study is intended to compare several different doses of AQUAVAN in patients having a colonoscopy in order to find the right dose that will get patients to a level of mild to moderate (procedural) sedation.
Timeline
- Start
- 2005-07
- Primary completion
- —
- Completion
- 2005-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Midazolam | Small molecule | 0.02 mg/kg | Intravenous |
| Subject | fospropofol | Small molecule | 2 mg/kg | Intravenous |
| Subject | fospropofol | Small molecule | 5 mg/kg | Intravenous |
| Subject | fospropofol | Small molecule | 6.5 mg/kg | Intravenous |
| Subject | fospropofol | Small molecule | 8 mg/kg | Intravenous |