Comparison of a lower-lipid propofol emulsion with the standard emulsion for sedation during monitored anesthesia care.
BACKGROUND
The currently used emulsion formulations of 1% propofol contain 10% soybean oil. However, a new emulsion of 1% propofol (Ampofol) containing 50% less lipid has recently become available for clinical investigation. This study was designed to compare the pharmacodynamic properties of Ampofol with those of a standard formulation (Diprivan) when administered for intraoperative sedation.


METHODS
Sixty healthy outpatients undergoing minor operations with local anesthesia were randomly assigned to receive either Ampofol (n = 31) or Diprivan (n = 29) for intravenous sedation. The sedation was initiated with an intravenous loading dose of propofol, 0.75 mg/kg, followed by an initial infusion rate of 50 microg x kg(-1) x min(-1) to achieve an Observer's Assessment of Alertness/Sedation score of 3. The targeted level of sedation was maintained with a variable-rate propofol infusion during the operation. The onset times to achieving a sedation score of 3, the severity of pain on injection of the loading dose, intraoperative hemodynamic variables, and electroencephalographic Bispectral Index values were recorded. In addition, recovery times, postoperative pain and nausea, and patient satisfaction with the sedative medication were assessed.


RESULTS
There were no significant differences between Ampofol and Diprivan with respect to onset times, dosage requirements, Bispectral Index values, hemodynamic variables, recovery times, or patient satisfaction scores. The incidence of moderate pain on injection was higher in the Ampofol group (26%vs. 7% with Diprivan; P < 0.05).


CONCLUSIONS
Ampofol was equipotent to Diprivan with respect to its sedative properties during monitored anesthesia care. Although both groups received pretreatment with intravenous lidocaine, Ampofol was associated with more pain on injection.
Song
Dajun
D
Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA.
Hamza
Mohamed A
MA
White
Paul F
PF
Byerly
Stephanie I
SI
Jones
Stephanie B
SB
Macaluso
Amy D
AD
D000328:Adult; D000368:Aged; D000762:Anesthesia Recovery Period; D018686:Anesthetics, Intravenous / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D004311:Double-Blind Method; D004569:Electroencephalography / Q000187:drug effects / Q000379:methods; D005217:Fat Emulsions, Intravenous / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D016343:Monitoring, Intraoperative / Q000379:methods*; D015742:Propofol / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D018709:Statistics, Nonparametric
D018686:Anesthetics, Intravenous; D005217:Fat Emulsions, Intravenous; D006993:Hypnotics and Sedatives; D015742:Propofol