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

• Status: Terminated
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: Eisai Inc.
• Treatments: Anesthetics; Fentanyl; Fospropofol; Midazolam; Propofol

Criteria

Inclusion Criteria:

• 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 Criteria:

• History of allergic reaction or hypersensitivity to any anesthetic agent, opioid, or benzodiazepine

• Fentanyl citrate injection or midazolam hydrocholoride injection contraindicated