Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery

June 25, 2012 updated by: Mayo Clinic

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?

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10 mg/kg Lusedra
10 mg/kg Lusedra initial bolus.
Drug: Fospropofol disodium
10 mg/kg bolus
Other Names:
  • Lusedra
Drug: Fospropofol disodium
6.5 mg/kg bolus
Other Names:
  • 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:
  • Fentanyl Citrate
  • Sublimaze
Active Comparator: 6.5 mg/kg Lusedra
6.5 mg/kg Lusedra initial bolus.
Drug: Fospropofol disodium
10 mg/kg bolus
Other Names:
  • Lusedra
Drug: Fospropofol disodium
6.5 mg/kg bolus
Other Names:
  • 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:
  • Fentanyl Citrate
  • Sublimaze
Active Comparator: Placebo + Midazolam
Placebo initial bolus with dose of midazolam based on patient's weight
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:
  • Fentanyl Citrate
  • Sublimaze
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 Names:
  • Versed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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."
approximately 4 minutes after administration of first bolus of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Eisai Inc.

Investigators

  • Principal Investigator: John B Leslie, MD MBA, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

September 1, 2010

First Submitted That Met QC Criteria

September 2, 2010

First Posted (Estimate)

September 3, 2010

Study Record Updates

Last Update Posted (Estimate)

June 29, 2012

Last Update Submitted That Met QC Criteria

June 25, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-000721

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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