Conditions: Procedural Sedation Regional Anesthesia Block Orthopedic Surgery
Keywords: Procedural sedation Regional Anesthesia block Orthopedic surgery Lusedra Fospropofol disodium Midazolam
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 13
Healthy volunteers: no

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

Detailed description:
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.

Arms:
arm 1: 10 mg/kg Lusedra initial bolus. arm 2: 6.5 mg/kg Lusedra initial bolus. arm 3: Placebo initial bolus with dose of midazolam based on patient's weight

Interventions: intervention 1: Fospropofol disodium intervention 2: Fospropofol disodium intervention 3: Placebo + Midazolam intervention 4: Fentanyl
Intervention descriptions: intervention 1: 10 mg/kg bolus intervention 2: 6.5 mg/kg bolus intervention 3: Placebo bolus plus midazolam. The dose of midazolam will be based on the patient's weight: 1 mg for patients \<60 kg; 1.5 mg for patients ≥60 kg to \<90 kg; or 2 mg for patients ≥90 kg intervention 4: All patients will receive a single dose of IV fentanyl (approximately 1 μg/kg not to exceed: 50 μg for patients \<60 kg; 75 μg for patients ≥90 kg) five minutes prior to the initial dose of sedative.

Protocol document: