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AQUAVAN Safety in Minor Surgery
NCT00327392Phase 3
Key facts
- Status
- Completed
- Start
- May 2006
- Countries
- 1
- Sponsor
- Eisai Co., Ltd.
- Modality
- Prodrugs/Conditional Activator Small Molecules
- Drugs
- fospropofol disodium
- Conditions
- Procedural sedation (PS)
01
Overview
Phase 3, open-label, single-arm trial of fospropofol disodium in Procedural sedation (PS), sponsored by Eisai Co., Ltd. Primary endpoint: Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures at 2 hours. Started May 2006; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
AQUAVAN
Patients receive AQUAVAN (fospropofol disodium) for sedation.
03
Who it enrols
Adult patients (18+) undergoing minor surgical procedures requiring minimal-to-moderate sedation, with ASA status P1-P4, and meeting NPO guidelines. Excludes patients with difficult airways, significant ECG abnormalities, or allergies to opioids/anesthetics.
04
Endpoints
Primary
Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures
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