P. Diemunsch et al., INTRAVENOUS DOLASETRON MESILATE AMELIORATES POSTOPERATIVE NAUSEA AND VOMITING, Canadian journal of anaesthesia, 44(2), 1997, pp. 173-181
Purpose: To compare the efficacy, safety, and tolerability of dolasetr
on mesilate with placebo for the treatment of postoperative nausea and
vomiting (PONV). Methods: in a randomized, multicentre, double-blind,
placebo-controlled study 337 adult patients undergoing surgery with g
eneral anaesthesia received one of four single, doses of dolasetron me
silate iv (i 2.5, 25, 50, or 100 mg) or placebo, Study medication was
administered postoperatively when the patient reported nausea lasting
10 min or when one emetic episode occurred within two hours of the pat
ient's arrival in the recovery room, Efficacy was assessed by the inve
stigators over the 24-hr study period by recording the number and timi
ng of emetic episodes, the severity of nausea, the timing of administr
ation of escape antiemetic medications, and patients' and investigator
s' satisfaction with antiemetic therapy. Results: The study sample was
predominately women, and the surgical procedures were primarily gynae
cological, All dolasetron mesilate doses produced higher complete resp
onse rates than placebo (P < 0.05). Only approximately one-third of do
lasetron patients required escape antiemetic medication compared with
more than 50% of patients in the placebo group. Both patient and physi
cian satisfaction with dolasetron treatment was high. The most common
adverse event was mild or moderate headache for both placebo-treated p
atients and dolasetron-treated patients. Clinical laboratory results w
ere unremarkable. Conclusion: Single doses of dolasetron mesilate iv,
given after the first episode of PONV were both effective and safe in
this adult patient population.