Status:
TERMINATED
Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Eisai Inc.
Conditions:
Procedural Sedation
Regional Anesthesia Block
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
How does Lusedra compare with current standard of care (midazolam) for minimal to moderate sedation for regional anesthesia blocks prior to orthopedic surgery?
Detailed Description
The study overall is aimed at establishing the superiority of a single intravenous bolus-dose of Lusedra for routine use in preoperative regional blocks that avoids deeper levels of sedation and incre...
Eligibility Criteria
Inclusion
- Undergoing elective orthopedic surgery
- With a regional block prior to surgery
- Able to consent and complete the assessments and procedures
- If female, must be surgically sterile, postmenopausal, or not pregnant or lactating and using an acceptable method of birth control for at least 1 month prior to surgery with a negative urine pregnancy test at screening
- American Society of Anesthesiologists Physical Classification System status category P1 to P4
Exclusion
- History of allergic reaction or hypersensitivity to any anesthetic agent, opioid, or benzodiazepine
- Fentanyl citrate injection or midazolam hydrocholoride injection contraindicated
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01195103
Start Date
February 1 2011
End Date
March 1 2011
Last Update
June 29 2012
Active Locations (1)
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1
Mayo Clinic
Phoenix, Arizona, United States, 85054