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David P Seamans
Bolus-Dose Fospropofol Disodium (Lusedra®): Is 10 mg/Kg Superior To 6.5 mg/Kg for Sedation in Patients Undergoing Regional Anesthesia Blocks Prior to Orthopedic Surgery?
Author(s): John B Leslie, Terrence L Trentman, Lopa Misra, David M Rosenfeld, David P Seamans, Renee E Caswell, André R Watkins, Joseph G Hentz and Ryan BuckleyJohn B Leslie, Terrence L Trentman, Lopa Misra, David M Rosenfeld, David P Seamans, Renee E Caswell, André R Watkins, Joseph G Hentz and Ryan Buckley
Objective: Fospropofol disodium (Lusedra®) is a pro-drug propofol for Monitored Anesthesia Care. The FDA-approved dose regimen is minimally effective with a slow onset often requiring supplemental doses at 4 minutes to achieve adequate sedation and frequently requires early re-dosing. This study was designed to assess if a larger initial bolus dose of 10 mg/kg could achieve successful sedation without supplemental doses and without an increase in sedation-related adverse events. Methods: An IRB-approved trial enrolled 12 adults undergoing elective orthopedic surgery with regional block. After IV fentanyl 50-75 micrograms, patients were randomly assigned into three IV bolus groups: fospropofol 6.5 mg/kg, fospropofol 10 mg/kg, or placebo with midazolam for rescue sedation if needed. Following the initial bolus, the level of sedation was me.. View More»