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

This study has been terminated.
(Funding terminated by funding source.)
Sponsor:
Collaborator:
Eisai Inc.
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01195103
First received: September 1, 2010
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

How does Lusedra compare with current standard of care (midazolam) for minimal to moderate sedation for regional anesthesia blocks prior to orthopedic surgery?


Condition Intervention Phase
Procedural Sedation
Regional Anesthesia Block
Orthopedic Surgery
Drug: Fospropofol disodium
Drug: Placebo + Midazolam
Drug: Fentanyl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Percentage of Participants Achieving Sedation Within 4 Minutes [ Time Frame: approximately 4 minutes after administration of first bolus of study drug ] [ Designated as safety issue: No ]
    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."


Enrollment: 13
Study Start Date: February 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10 mg/kg Lusedra
10 mg/kg Lusedra initial bolus.
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:
  • Fentanyl Citrate
  • Sublimaze
Active Comparator: 6.5 mg/kg Lusedra
6.5 mg/kg Lusedra initial bolus.
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:
  • Fentanyl Citrate
  • Sublimaze
Active Comparator: Placebo + Midazolam
Placebo initial bolus with dose of midazolam based on patient's weight
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:
  • Fentanyl Citrate
  • Sublimaze

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: John B Leslie MD MBA, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01195103     History of Changes
Other Study ID Numbers: 10-000721
Study First Received: September 1, 2010
Results First Received: February 27, 2012
Last Updated: June 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Procedural sedation
Regional Anesthesia block
Orthopedic surgery
Lusedra
Fospropofol disodium
Midazolam

Additional relevant MeSH terms:
Anesthetics
Midazolam
Fentanyl
Propofol
Fospropofol
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014