Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery
This study has been terminated.
(Funding terminated by funding source.)
Sponsor:
Mayo Clinic
Collaborator:
Eisai Inc.
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01195103
First received: September 1, 2010
Last updated: June 25, 2012
Last verified: June 2012
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Purpose
How does Lusedra compare with current standard of care (midazolam) for minimal to moderate sedation for regional anesthesia blocks prior to orthopedic surgery?
| Condition | Intervention | Phase |
|---|---|---|
|
Procedural Sedation Regional Anesthesia Block Orthopedic Surgery |
Drug: Fospropofol disodium Drug: Placebo + Midazolam Drug: Fentanyl |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Fentanyl
Fentanyl citrate
Midazolam hydrochloride
Fospropofol disodium
U.S. FDA Resources
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- Percentage of Participants Achieving Sedation Within 4 Minutes [ Time Frame: approximately 4 minutes after administration of first bolus of study drug ] [ Designated as safety issue: No ]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."
| Enrollment: | 13 |
| Study Start Date: | February 2011 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 10 mg/kg Lusedra
10 mg/kg Lusedra initial bolus.
|
Drug: Fospropofol disodium
10 mg/kg bolus
Other Name: Lusedra
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.
Other Names:
|
|
Active Comparator: 6.5 mg/kg Lusedra
6.5 mg/kg Lusedra initial bolus.
|
Drug: Fospropofol disodium
6.5 mg/kg bolus
Other Name: Lusedra
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.
Other Names:
|
|
Active Comparator: Placebo + Midazolam
Placebo initial bolus with dose of midazolam based on patient's weight
|
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
Other Name: Versed
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.
Other Names:
|
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| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | John B Leslie MD MBA, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01195103 History of Changes |
| Other Study ID Numbers: | 10-000721 |
| Study First Received: | September 1, 2010 |
| Results First Received: | February 27, 2012 |
| Last Updated: | June 25, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mayo Clinic:
|
Procedural sedation Regional Anesthesia block Orthopedic surgery |
Lusedra Fospropofol disodium Midazolam |
Additional relevant MeSH terms:
|
Anesthetics Midazolam Fentanyl Propofol Fospropofol disodium Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Adjuvants, Anesthesia Anti-Anxiety Agents Tranquilizing Agents |
Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 21, 2013