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

NCT01195103 | Terminated Phase 4 Results

• 1 other identifier: 10-000721
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Procedural Sedation; Regional Anesthesia Block; Orthopedic Surgery

Keywords

Procedural sedation; Regional Anesthesia block; Orthopedic surgery; Lusedra; Fospropofol disodium; Midazolam

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

10 mg/kg Lusedra

EXPERIMENTAL

10 mg/kg Lusedra initial bolus.

Drug: Fospropofol disodium; Drug: Fentanyl

6.5 mg/kg Lusedra

ACTIVE COMPARATOR

6.5 mg/kg Lusedra initial bolus.

Drug: Fospropofol disodium; Drug: Fentanyl

Placebo + Midazolam

ACTIVE COMPARATOR

Placebo initial bolus with dose of midazolam based on patient's weight

Drug: Placebo + Midazolam; Drug: Fentanyl

Interventions

Fospropofol disodium DRUG

10 mg/kg bolus

Also known as: Lusedra

10 mg/kg Lusedra

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

Also known as: Versed

Placebo + Midazolam

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.

Also known as: Fentanyl Citrate, Sublimaze

10 mg/kg Lusedra; 6.5 mg/kg Lusedra; Placebo + Midazolam

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of allergic reaction or hypersensitivity to any anesthetic agent, opioid, or benzodiazepine
• Fentanyl citrate injection or midazolam hydrocholoride injection contraindicated

Sponsors & Collaborators

• Mayo Clinic: lead
• Eisai Inc.: collaborator

Study Sites (1)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

MeSH Terms

Interventions

fospropofol; Midazolam; Fentanyl

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

The study was terminated early because funding was terminated by the funding source.

Results Point of Contact

• Title: John B Leslie MD
• Organization: Mayo Clinic

leslie.john@mayo.edu

480-301-8000

Study Officials

• John B Leslie, MD MBA

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: September 3, 2010
• Study Start: February 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 29, 2012
• Results First Posted: March 29, 2012

Record last verified: 2012-06

Locations

US (1)