NCT01195103

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

A Prospective Randomized Study to Assess the Efficacy and Safety of Bolus-dose Lusedra (Fospropofol Disodium) 6.5 mg/kg or 10 mg/kg Versus a Placebo (With Midazolam Rescue) for Minimal-to-moderate Sedation in Patients Undergoing Procedural Sedation for Regional Anesthesia Blocks Prior to Orthopedic Surgery

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Procedural Sedation
• Regional Anesthesia Block
• Orthopedic Surgery

Interventions

Type	Name	Description
DRUG	Fospropofol disodium	10 mg/kg bolus
DRUG	Fospropofol disodium	6.5 mg/kg bolus
DRUG	Placebo + Midazolam	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
DRUG	Fentanyl	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.

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2010-09-03
• Last updated: 2012-06-29
• Results posted: 2012-03-29

Locations

1 site across 1 country: United States