Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery
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| ClinicalTrials.gov Identifier: NCT01195103 |
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Recruitment Status :
Terminated
(Funding terminated by funding source.)
First Posted : September 3, 2010
Results First Posted : March 29, 2012
Last Update Posted : June 29, 2012
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Sponsor:
Mayo Clinic
Collaborator:
Eisai Inc.
Information provided by:
Mayo Clinic
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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?
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Procedural Sedation Regional Anesthesia Block Orthopedic Surgery | Drug: Fospropofol disodium Drug: Placebo + Midazolam Drug: Fentanyl | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 13 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | February 2011 |
| Actual Primary Completion Date : | March 2011 |
| Actual Study Completion Date : | March 2011 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: 10 mg/kg Lusedra
10 mg/kg Lusedra initial bolus.
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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:
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Active Comparator: 6.5 mg/kg Lusedra
6.5 mg/kg Lusedra initial bolus.
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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:
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Active Comparator: Placebo + Midazolam
Placebo initial bolus with dose of midazolam based on patient's weight
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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:
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Primary Outcome Measures :
- Percentage of Participants Achieving Sedation Within 4 Minutes [ Time Frame: 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."
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01195103
Locations
| United States, Arizona | |
| Mayo Clinic | |
| Phoenix, Arizona, United States, 85054 | |
Sponsors and Collaborators
Mayo Clinic
Eisai Inc.
Investigators
| Principal Investigator: | John B Leslie, MD MBA | Mayo Clinic |
Additional Information:
| Responsible Party: | John B Leslie MD MBA, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01195103 |
| Other Study ID Numbers: |
10-000721 |
| First Posted: | September 3, 2010 Key Record Dates |
| Results First Posted: | March 29, 2012 |
| Last Update Posted: | June 29, 2012 |
| Last Verified: | June 2012 |
Keywords provided by Mayo Clinic:
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Procedural sedation Regional Anesthesia block Orthopedic surgery |
Lusedra Fospropofol disodium Midazolam |
Additional relevant MeSH terms:
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Fentanyl Midazolam Propofol Fospropofol Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia |
Anesthetics, Intravenous Anesthetics, General Anesthetics Hypnotics and Sedatives Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |