A Phase 4 interventional study of Fospropofol disodium and Fospropofol disodium in Procedural Sedation, Regional Anesthesia Block and Orthopedic Surgery, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-06-29.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Treatment
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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Exclusion Criteria:
10 mg/kg Lusedra initial bolus.
Drug: Fospropofol disodium · Drug: Fentanyl
6.5 mg/kg Lusedra initial bolus.
Drug: Fospropofol disodium · Drug: Fentanyl
Placebo initial bolus with dose of midazolam based on patient's weight
Drug: Placebo + Midazolam · Drug: Fentanyl
10 mg/kg bolus
Also known as: Lusedra
6.5 mg/kg bolus
Also known as: Lusedra
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
Also known as: Versed
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.
Also known as: Fentanyl Citrate, Sublimaze
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."
Time frame: approximately 4 minutes after administration of first bolus of study drug
Patients were recruited from Mayo Clinic, Arizona from March 1 - 11, 2011.
| Milestone | 10 mg/kg Lusedra | 6.5 mg/kg Lusedra | Placebo + Midazolam |
|---|---|---|---|
| Started | 6 | 2 | 5 |
| Completed | 5 | 2 | 5 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
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."
| percentage of participants | 10 mg/kg Lusedra | 6.5 mg/kg Lusedra | Placebo + Midazolam |
|---|---|---|---|
| Percentage of Participants Achieving Sedation Within 4 Minutes | 100 | 50 | 40 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 10 mg/kg Lusedra | — | 1/5 (20%) | 5/5 (100%) |
| 6.5 mg/kg Lusedra | — | 0/2 (0%) | 1/2 (50%) |
| Placebo + Midazolam | — | 0/5 (0%) | 2/5 (40%) |
| Event | 10 mg/kg Lusedra | 6.5 mg/kg Lusedra | Placebo + Midazolam |
|---|---|---|---|
| apneaRespiratory, thoracic and mediastinal disorders | 1/5 | 0/2 | 0/5 |
| Event | 10 mg/kg Lusedra | 6.5 mg/kg Lusedra | Placebo + Midazolam |
|---|---|---|---|
| deep sedationNervous system disorders | 5/5 | 0/2 | 1/5 |
| puritisSkin and subcutaneous tissue disorders | 3/5 | 1/2 | 0/5 |
| delayed recovery from sedationNervous system disorders | 2/5 | 0/2 | 2/5 |
| Age Continuous(years) | 10 mg/kg Lusedra | 6.5 mg/kg Lusedra | Placebo + Midazolam | Total |
|---|---|---|---|---|
| Mean | 73.2 ± 7.0 | 71.5 ± 4.3 | 72 ± 12 | 72.6 ± 8.2 |
| Sex: Female, Male(Participants) | 10 mg/kg Lusedra | 6.5 mg/kg Lusedra | Placebo + Midazolam | Total |
|---|---|---|---|---|
| Female | 4 | 0 | 4 | 8 |
| Male | 2 | 2 | 1 | 5 |
This study is terminated, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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