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Funding terminated by funding source.
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| Name | Class |
|---|---|
| Eisai Inc. | INDUSTRY |
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How does Lusedra compare with current standard of care (midazolam) for minimal to moderate sedation for regional anesthesia blocks prior to orthopedic surgery?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 mg/kg Lusedra | Experimental | 10 mg/kg Lusedra initial bolus. |
|
| 6.5 mg/kg Lusedra | Active Comparator | 6.5 mg/kg Lusedra initial bolus. |
|
| Placebo + Midazolam | Active Comparator | Placebo initial bolus with dose of midazolam based on patient's weight |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fospropofol disodium | Drug | 10 mg/kg bolus |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John B Leslie, MD MBA | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States |
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Patients were recruited from Mayo Clinic, Arizona from March 1 - 11, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | 10 mg/kg Lusedra | 10 mg/kg Lusedra initial bolus |
| FG001 | 6.5 mg/kg Lusedra | 6.5 mg/kg Lusedra initial bolus |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Fospropofol disodium | Drug | 6.5 mg/kg bolus |
|
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| Placebo + Midazolam | Drug | 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 |
|
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| Fentanyl | Drug | 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. |
|
|
| FG002 |
| Placebo + Midazolam |
Placebo initial bolus with dose of midazolam based on patient's weight |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 10 mg/kg Lusedra | 10 mg/kg Lusedra initial bolus |
| BG001 | 6.5 mg/kg Lusedra | 6.5 mg/kg Lusedra initial bolus |
| BG002 | Placebo + Midazolam | Placebo initial bolus with dose of midazolam based on patient's weight |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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." | Posted | Number | percentage of participants | approximately 4 minutes after administration of first bolus of study drug |
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Patients were followed for adverse events from the time of drug administration until entry into the operating room. Patients were sedated again for the surgery. We only studied the first sedation.
No adverse event data were collected for the patient who withdrew prior to receiving study drug, so that patient was not included in the assessment of adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 10 mg/kg Lusedra | 10 mg/kg Lusedra initial bolus | 1 | 5 | 5 | 5 | ||
| EG001 | 6.5 mg/kg Lusedra | 6.5 mg/kg Lusedra initial bolus | 0 | 2 | 1 | 2 | ||
| EG002 | Placebo + Midazolam | Placebo initial bolus with dose of midazolam based on patient's weight | 0 | 5 | 2 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| deep sedation | Nervous system disorders | Systematic Assessment |
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| delayed recovery from sedation | Nervous system disorders | Systematic Assessment |
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| puritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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The study was terminated early because funding was terminated by the funding source.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John B Leslie MD | Mayo Clinic | 480-301-8000 | leslie.john@mayo.edu |
| ID | Term |
|---|---|
| C472965 | fospropofol |
| D008874 | Midazolam |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Male |
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