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.
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
Last updated: 06/25/2012
NCT ID: NCT01195103
IRB Number:10-000721
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