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

PHASE4TerminatedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions
Procedural SedationRegional Anesthesia BlockOrthopedic Surgery
Interventions
DRUG

Fospropofol disodium

10 mg/kg bolus

DRUG

Fospropofol disodium

6.5 mg/kg bolus

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

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.

Trial Locations (1)

85054

Mayo Clinic, Phoenix

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

Mayo Clinic

OTHER