Procedural SedationPhase 4NCT01195103
Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery
A Phase 4 study testing Fospropofol disodium and Fentanyl in people with Procedural Sedation and Regional Anesthesia Block, run by Mayo Clinic at 1 site in United States.
Trial summary
How does Lusedra compare with current standard of care (midazolam) for minimal to moderate sedation for regional anesthesia blocks prior to orthopedic surgery? Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Procedural Sedation, Regional Anesthesia Block, Orthopedic Surgery
- What is being tested?
- Fospropofol disodium and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Mar 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of allergic reaction or hypersensitivity to any anesthetic agent, opioid, or benzodiazepine
- Fentanyl citrate injection or midazolam hydrocholoride injection contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
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
How does Lusedra compare with current standard of care (midazolam) for minimal to moderate sedation for regional anesthesia blocks prior to orthopedic surgery?
Read the 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.
- Being tested
- Fospropofol disodium, Placebo + Midazolam, Fentanyl
- Keywords
- Procedural sedation, Regional Anesthesia block, Orthopedic surgery, Lusedra, Fospropofol disodium, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fospropofol disodiumDrug
Also called Lusedra
10 mg/kg bolus
Fospropofol disodiumDrug
Also called Lusedra
6.5 mg/kg bolus
Placebo + MidazolamDrug
Also called Versed
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
FentanylDrug
Also called Fentanyl Citrate, Sublimaze
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.
| Study group | Role | What they receive |
|---|---|---|
| 10 mg/kg Lusedra | Experimental | 10 mg/kg Lusedra initial bolus. Receives: Drug: Fospropofol disodium; Drug: Fentanyl |
| 6.5 mg/kg Lusedra | Active comparator | 6.5 mg/kg Lusedra initial bolus. Receives: Drug: Fospropofol disodium; Drug: Fentanyl |
| Placebo + Midazolam | Active comparator | Placebo initial bolus with dose of midazolam based on patient's weight Receives: Drug: Placebo + Midazolam; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: approximately 4 minutes after administration of first bolus of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startFeb 2011
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Funding terminated by funding source.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Investigators
- John B Leslie, MD MBA, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195103
- Sponsor's protocol ID
- 10-000721
- Status last verified
- Jun 2012
- First submitted
- 1 Sep 2010
- Last updated
- 29 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01195103
- Acronym / sponsor ID
- 10-000721
- Keywords
- Procedural sedation, Regional Anesthesia block, Orthopedic surgery, Lusedra, Fospropofol disodium, Midazolam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding terminated by funding source.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Feb 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 3 Sep 2010 (estimated)
- Results
- Posted 29 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
How does Lusedra compare with current standard of care (midazolam) for minimal to moderate sedation for regional anesthesia blocks prior to orthopedic surgery?
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 mg/kg Lusedra | Experimental | Drug: Fospropofol disodium, Drug: Fentanyl10 mg/kg Lusedra initial bolus. |
| 6.5 mg/kg Lusedra | Active comparator | Drug: Fospropofol disodium, Drug: Fentanyl6.5 mg/kg Lusedra initial bolus. |
| Placebo + Midazolam | Active comparator | Drug: Placebo + Midazolam, Drug: FentanylPlacebo initial bolus with dose of midazolam based on patient's weight |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- History of allergic reaction or hypersensitivity to any anesthetic agent, opioid, or benzodiazepine
- Fentanyl citrate injection or midazolam hydrocholoride injection contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fospropofol disodiumAlso: Lusedra10 mg/kg bolus | Drug | 10 mg/kg Lusedra |
| Fospropofol disodiumAlso: Lusedra6.5 mg/kg bolus | Drug | 6.5 mg/kg Lusedra |
| Placebo + MidazolamAlso: VersedPlacebo 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 | Drug | Placebo + Midazolam |
| FentanylAlso: Fentanyl Citrate, SublimazeAll 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. | Drug | 10 mg/kg Lusedra, 6.5 mg/kg Lusedra, Placebo + Midazolam |
Primary outcome
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."
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John B Leslie, MD MBA principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fospropofol disodium and Fentanyl in people with Procedural Sedation and Regional Anesthesia Block, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Sedation Within 4 Minutes (time frame: approximately 4 minutes after administration of first bolus of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2012.