Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mayo Clinic
With
Eisai Inc.
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 increased risk of nerve damage in an over-sedated individual. The shorter half-life of Lusedra should also demonstrate a superior recovery profile compared to midazolam when used as a rescue comparator. While this study will only enroll patients undergoing regional blocks prior to orthopedic surgery, the clinical utility and value of the larger initial intravenous dosing for Lusedra may be evident for many different monitored anesthesia care anesthetic management situations requiring rapid and effective onset of effects.
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be if
History of allergic reaction or hypersensitivity to any anesthetic agent, opioid, or benzodiazepine
Fentanyl citrate injection or midazolam hydrocholoride injection contraindicated
Clareo Health | Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery
