The central objectives of this study were to evaluate the cognitive, psychomotor and subjective effects of two
anti-emetic drugs of established value in the prophylaxis of radiation induced
nausea and
vomiting. The drugs of interest were
granisetron (
Kytril, SmithKline Beecham
Pharmaceuticals, Philadelphia, PA; 1 mg
tablets/2 mg dose) and
ondansetron (
Zofran, Glaxo Welcome, Inc., Research Triangle Park, NC; 8 mg
tablets/8 mg dose). The experimental approach, involving 24 active-duty military subjects, was a placebo controlled, double blind, crossover design with a positive control (
prochlorperazine, 10 mg
tablets/10 mg dose) condition. Testing was accomplished during the evening and early morning hours, between 1630 hours and 0230 hours. Therefore,
fatigue stemming from an extended work period and a disrupted work/rest cycle was also part of the study design. Data were collected on the following: cognitive and psychomotor effects, affective state changes, temperature, serum
drug levels, and side effects. The drugs of interest,
granisetron and
ondansetron, were extremely well tolerated, with no obvious side effects when compared to the placebo condition. Two of five cognitive tests detected a positive control effect and nearly all of the measurement instruments demonstrated a general
fatigue effect, independent of the
drug. There was no evidence of any cognitive, psychomotor or subjective state changes caused by either
granisetron or
ondansetron. It was concluded the
anti-emetic drugs,
granisetron or
ondansetron, would not interfere with performance when given prophylactically to personnel at risk of exposure to radiation.