Intravenous dolasetron mesilate in the prevention of postoperative nausea and vomiting in females undergoing gynecological surgery.
OBJECTIVE
To evaluate a range of doses of intravenous (i.v.) dolasetron mesilate, in preventing postoperative nausea and vomiting (PONV).


METHODS
Double-blind, placebo-controlled, randomized, multicenter trial.


METHODS
Ten hospitals and/or surgical centers.


METHODS
281 women undergoing gynecologic surgery with general anesthesia.


METHODS
Patients received one of four single, i.v. doses of dolasetron mesilate (12.5 mg, 25 mg, 50 mg, and 100 mg) or placebo administered following cessation of anesthesia.


RESULTS
Patients were monitored for 24 hours following study drug administration. The antiemetic efficacy of each dolasetron mesilate dose was evaluated by recording the number and timing of emetic episodes, and the effects on nausea were assessed by use of visual analog scales (VAS). Safety was assessed by adverse event reports, clinical laboratory tests, electrocardiographic (ECG) measurements, and monitoring vital signs. Complete responses (patients with no emetic episodes and no escape antiemetic medication requirements in 24 hours) were achieved by 54% in the 12.5-mg, 67% in the 25-mg, and 59% in both the 50-mg and 100-mg dolasetron mesilate dose groups, and by 43% in the placebo group. Nausea VAS assessments demonstrated that dolasetron-treated patients were significantly (p = 0.048) more likely to report no nausea (VAS score < 5 mm) than those in the placebo group. Adverse events reported generally were mild in intensity, and there were no clinically significant changes in laboratory tests, vital signs, or ECG parameters.


CONCLUSIONS
Dolasetron was effective and well tolerated for the prevention of PONV in female patients undergoing gynecologic surgery with general anesthesia.
Diemunsch
P
P
Department of Anesthesiology, Les Hôpitaux Universitaires de Strasbourg, France.
D'Hollander
A
A
Paxton
L
L
Schoeffler
P
P
Wessel
P
P
Navé
S
S
Brown
R A
RA
Hahne
W F
WF
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D000932:Antiemetics / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005831:Genital Diseases, Female / Q000601:surgery; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D007275:Injections, Intravenous; D008875:Middle Aged; D009325:Nausea / Q000209:etiology / Q000517:prevention & control*; D011183:Postoperative Complications / Q000517:prevention & control*; D011807:Quinolizines / Q000009:adverse effects / Q000627:therapeutic use*; D012702:Serotonin Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014839:Vomiting / Q000209:etiology / Q000517:prevention & control*
D000932:Antiemetics; D007211:Indoles; D011807:Quinolizines; D012702:Serotonin Antagonists; C060344:dolasetron