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

Orthopedic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01195103
• Other study ID #: 10-000721
• Status: Terminated
• Phase: Phase 4
• First received: September 1, 2010
• Last updated: June 25, 2012
• Start date: February 2011
• Est. completion date: March 2011

Study information

• Verified date: June 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Orthopedic Surgery
• Procedural Sedation
• Regional Anesthesia Block

Intervention

Drug:
• Fospropofol disodium
10 mg/kg bolus
• Fospropofol disodium
6.5 mg/kg bolus
• 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
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Sedation Within 4 Minutes	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."	approximately 4 minutes after administration of first bolus of study drug	No

External Links

•   Mayo Clinic Clinical Trials