Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Procedural Sedation, Regional Anesthesia Block, Orthopedic Surgery

In brief

How does Lusedra compare with current standard of care (midazolam) for minimal to moderate sedation for regional anesthesia blocks prior to orthopedic surgery?

Key facts

Study ID

NCT01195103

Run by

Mayo Clinic

People needed

13

Starts

2011-02-01

Expected to finish

2011-03-01

Last updated by the study team

2012-06-29

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• History of allergic reaction or hypersensitivity to any anesthetic agent, opioid, or benzodiazepine
• Fentanyl citrate injection or midazolam hydrocholoride injection contraindicated

Where it is running

• Mayo Clinic — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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