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Canadian Journal of Anesthesia 51:A68 (2004)
© Canadian Anesthesiologists' Society, 2004

Abstracts - Tuesday June 22nd 2004 0800-1000

CARDIOVASCULAR SAFETY PROFILE OF AV430A IN HUMAN VOLUNTEERS

Matthew R. Belmont, MD, Joseph Tjan, MD, Cynthia A Lien, MD and Sanjay Patel, PhD

Department of Anesthesiology, New York Presbyterian Hospital-Cornell Medical Center, 525 East 68th Street, New York, NY 10021, USA

INTRODUCTION: AV430A is a new nondepolarizing neuromuscular blocking drug with a rapid onset and short duration of action. The ED95 is 0.125mg/kg1. The cardiovascular safety profile was studied in four groups from a larger phase 1 study.

METHODS: After IRB approval, 20 ASA class 1 male and female volunteers aged 18–48 yr were studied in 4 dose groups of five. Anesthesia was induced with midazolam, fentanyl, and propofol, and the tracheae were intubated without paralysis. Anesthesia was maintained with propofol, N2O 70%/O2 30%, and fentanyl as needed. BP(via intra-arterial radial line), HR, ETCO2, ECG, and Temp were monitored. Each subject received their first bolus dose of AV430A at least 20 minutes after intubation. The groups received 2, 3, 5, or 7X ED95 doses of AV430A (0.25, 0.375, 0.625, and 0.875 mg/kg respectively). Data were analyzed for maximum HR and BP changes in the first five minutes after the first drug bolus.

RESULTS: 15 of the 20 volunteers had less than 20% change in HR and/or MAP. One volunteer receiving 0.625mg/kg had a 30% decrease in MAP. At 7XED95 (0.875mg/kg), three had changes of 20–29% in HR and MAP and one had a 41% increase in HR. Table 1Go summarizes the mean maximum changes. All maximum hemodynamic changes occurred within 1.8 min. and were transient.


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  		Table 1:
 
DISCUSSION: All dose levels were well tolerated. Administration of AV430A in doses through 3XED95 were completely free of significant cardiovascular side effects. The 5XED95 dose caused significant side effects in one of the five volunteers in that group, and the 7XED95 group experienced significant, yet transient, changes. Since the onset at 5XED95 is approximately one minute1, higher doses are not likely to be recommended for clinical use.

REFERENCE:

1 Anesth. 99:A1153, 2003





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