Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Procedural Sedation; Regional Anesthesia Block; Orthopedic Surgery
Intervention: Fospropofol disodium (Drug); Fospropofol disodium (Drug); Placebo + Midazolam (Drug); Fentanyl (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s): John B Leslie, MD MBA, Principal Investigator, Affiliation: Mayo Clinic
Summary
How does Lusedra compare with current standard of care (midazolam) for minimal to moderate
sedation for regional anesthesia blocks prior to orthopedic surgery?
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percentage of Participants Achieving Sedation Within 4 Minutes
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Mayo Clinic, Phoenix, Arizona 85054, United States
Additional Information
Mayo Clinic Clinical Trials
Starting date: February 2011
Last updated: June 25, 2012
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