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

Phase 4

Terminated

• Conditions: Regional Anesthesia Block; Orthopedic Surgery; Procedural Sedation
• Interventions: Drug: Fospropofol disodium; Drug: Placebo + Midazolam; Drug: Fentanyl

• Registration Number: NCT01195103
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-02
• Study First Posted: 2010-09-03
• Study Start: 2011-02
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2012-02-27
• Results First Submitted QC: 2012-03-01
• Results First Posted: 2012-03-29
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-25
• Last Update Posted: 2012-06-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6.5 mg/kg Lusedra	Fospropofol disodium	6.5 mg/kg Lusedra initial bolus.
10 mg/kg Lusedra	Fospropofol disodium	10 mg/kg Lusedra initial bolus.
Placebo + Midazolam	Placebo + Midazolam	Placebo initial bolus with dose of midazolam based on patient's weight
10 mg/kg Lusedra	Fentanyl	10 mg/kg Lusedra initial bolus.
Placebo + Midazolam	Fentanyl	Placebo initial bolus with dose of midazolam based on patient's weight
6.5 mg/kg Lusedra	Fentanyl	6.5 mg/kg Lusedra initial bolus.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Sedation Within 4 Minutes	approximately 4 minutes after administration of first bolus of study drug	Percentage of patients achieving a Modified Observer's Assessment of Alertness/Sedation Scale score less than or equal to 4, and the block procedure initiated, within 4 minutes of the administration of the first bolus of study drug. The Modified Observer's Assessment of Alertness/Sedation Scale ranges from 0 (does not respond to deep stimulus) to 6 (agitated). The score of 4 equals "lethargic response to name spoken in normal tone."

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States