[Ondansetron. Prophylaxis and therapy of nausea and vomiting following major gynecologic procedures. Results of a national multicenter study].
This investigation was conducted as a national multicenter study to evaluate effectiveness and safety of prophylactic and therapeutic ondansetron for postoperative nausea and vomiting (PONV) in major gynaecological surgery.


METHODS
387 patients were randomised to receive either ondansetron 8 mg or placebo i.v. prior to anaesthesia induction. Anaesthesia was performed with a volatile anaesthetic, nitrous oxide and opioids. Established PONV was treated with ondansetron 4 mg i.v. Postoperative evaluation included time, duration and severeness of nausea and vomiting in the first 24 h after the operation.


RESULTS
In the study period the incidence of emesis was 35% after prophylactic ondansetron and 58% after placebo (p < 0.01). Nausea occurred in 49% and 64% respectively (p < 0.01). 28% after prophylactic ondansetron and 48% after placebo required ondansetron therapy (p < 0.01). The number of adverse events was small in total and comparable for both groups.


CONCLUSIONS
Our investigation proves the efficiency of ondansetron 8 mg prior to induction of anaesthesia in preventing PONV. Furthermore, our results demonstrate the safety of the drug for prophylaxis and therapy.
Klinik für Anaesthesiologie und Intensivmedizin, Universitätskliniken des Saarlandes.
A
A
Biedler
W
W
Wilhelm
M
M
Silomon
R
R
Awwad
R
R
Larsen
D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D013509:Gynecologic Surgical Procedures; D006801:Humans; D008875:Middle Aged; D009424:Nervous System Physiological Phenomena; D017294:Ondansetron / Q000009:adverse effects / Q000627:therapeutic use*; D020250:Postoperative Nausea and Vomiting / Q000503:physiopathology* / Q000517:prevention & control*; D011229:Preanesthetic Medication
D000932:Antiemetics; D017294:Ondansetron
Ondansetron. Prophylaxe und Therapie von Ubelkeit und Erbrechen nach grösseren gynäkologischen Eingriffen Ergebnisse einer nationalen Multizenterstudie.