Cardiovascular effects of i.v. granisetron at two administration rates and of ondansetron in healthy adults.

The cardiovascular effects of granisetron given as a 30-second i.v. bolus dose and of granisetron and ondansetron given by currently recommended methods were studied. Healthy adults 18 to 50 years of age were randomly assigned to one of four treatments during each of four study periods: granisetron 10 micrograms/kg (as the hydrochloride salt) i.v. over 5 minutes, granisetron 10 micrograms/kg i.v. over 30 seconds, ondansetron 32 mg (as the hydrochloride salt) i.v. over 15 minutes, and placebo. During each study period, the researchers gave each subject three sequential injections using a double-blind, double-dummy technique. Each subject was to receive all four regimens. Two resting 12-lead electrocardiograms (ECGs) were obtained before the regimen, and one was obtained at the end of each injection and at intervals up to 24 hours after the third injection. Sitting blood pressure and pulse were measured before treatments, immediately after the end of each injection, and at intervals up to 24 hours after injection 3. Safety data were analyzed for 13 subjects, and ECG interval data for 12 of them. The mean postdose QTc interval differed significantly among regimens. There were no other significant regimen-associated differences among the four mean results for any ECG interval. The mean post-dose QTc interval for ondansetron was significantly greater than that for each of the other regimens. The drug regimens were comparable in safety and tolerability. A total of 20 adverse effects, all mild to moderate, were reported in 10 subjects. Changes in vital signs were minimal. There were no clinically important cardiovascular changes associated with the i.v. administration of granisetron 10 micrograms/kg over 30 seconds, granisetron 10 micrograms/kg over 5 minutes, or ondansetron 32 mg over 15 minutes in healthy adults.

RCT Entities:   Population Interventions Outcomes