A Study of Lusedra (Fospropofol Disodium) for Use as Minimal to Moderate Sedation for Regional Anesthesia Nerve Blockage Prior to Orthopedic Surgery

Overview

About this study

The purpose of this study is to compare the safety and effectiveness of Lusedra with the current standard of care (midazolam) for minimal to moderate sedation, used with regional anesthesia nerve blocks for  orthopedic surgery.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

This study has been terminated

Inclusion Criteria

  • Undergoing elective orthopedic surgery
  • Using a regional block for surgery
  • Able to consent and complete the assessments and procedures
  • If female, must be
    • Surgically sterile
    • Postmenopausal
    • Not pregnant or lactating
    • Using an acceptable method of birth control for at least 1 month prior to surgery
    • Has 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

John Leslie, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20315810

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