European journal of anaesthesiology. Supplement
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Eur J Anaesthesiol Suppl · Nov 1992
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialOndansetron in the treatment of postoperative nausea and vomiting in ambulatory outpatients: a dose-comparative, stratified, multicentre study.
The safety and efficacy of ondansetron were evaluated in the treatment of postoperative nausea and vomiting. Five hundred patients who experienced nausea or vomiting in the Post-Anaesthesia Care Unit within the first 2 h of recovery were randomized to receive either 1, 4, or 8 mg of ondansetron, or placebo. All patients had undergone ambulatory surgery with general endotracheal anaesthesia. ⋯ The optimal dose of ondansetron for the treatment of postoperative nausea and vomiting was found to be 4 mg. All doses of ondansetron were well tolerated. No clinically significant increases in laboratory parameters or alterations in haemodynamic stability occurred in the ondansetron groups compared to placebo.
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Eur J Anaesthesiol Suppl · Nov 1992
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialProphylactic intravenous ondansetron in female outpatients undergoing gynaecological surgery: a multicentre dose-comparison study.
The efficacy and safety of prophylactic intravenous ondansetron in preventing postoperative nausea and vomiting was investigated in a randomized, stratified, double-blind, placebo-controlled, dose-comparison study of 580 ASA physical class I and II female outpatients undergoing gynaecological surgery and receiving general anaesthesia. Patients received either ondansetron 1, 4 or 8 mg, or placebo i.v. immediately prior to a standardized technique for induction and maintenance of anaesthesia. All patients were intubated and received nitrous oxide and a narcotic. ⋯ Ondansetron was generally well tolerated, as evidenced by an adverse event, laboratory safety, and vital sign profile similar to placebo. Ondansetron 4 mg was found to be the optimal prophylactic i.v. dose for female outpatients over the entire 24 h postoperative period. Higher doses may offer an added benefit in some patients, such as those with a history of nausea and vomiting following general anaesthesia.
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Eur J Anaesthesiol Suppl · Nov 1992
Randomized Controlled Trial Multicenter Study Clinical TrialOral ondansetron in the prevention of postoperative nausea and vomiting.
The effect of three times daily oral ondansetron in preventing postoperative nausea and vomiting was investigated in two randomized, double-blind, placebo-controlled, multi-centre studies. The first study compared ondansetron 1, 8 and 16 mg to placebo, and the second study compared 8 mg ondansetron to placebo. Both studies included ASA Class I-III female patients about to undergo major abdominal gynaecological surgery or vaginal hysterectomy. ⋯ Side-effects mainly consisted of constipation, headache, and asymptomatic elevation of liver enzymes. The incidence of side-effects was similar in ondansetron- and placebo-treated patients. There appeared to be no clinically important benefit of the 16 mg three times daily ondansetron regimen over the 8 mg three times daily dose, therefore 8 mg three times daily is recommended as the optimal oral dose in the prevention of postoperative nausea and vomiting.
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Eur J Anaesthesiol Suppl · Nov 1992
ReviewThe clinical development of ondansetron for use in the prevention and treatment of postoperative nausea and vomiting.
An international clinical trial programme has been established to assess the efficacy and safety of ondansetron in the prevention and treatment of postoperative nausea and vomiting. The programme included nine pilot studies and six key placebo-controlled studies. ⋯ The primary efficacy analysis for emesis was based on the assessment of complete response (i.e. absence of emetic episodes or nausea in the first 24 h postoperatively). These trials clearly demonstrated the anti-emetic efficacy of ondansetron in the prevention and treatment of postoperative nausea and vomiting.
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Eur J Anaesthesiol Suppl · Nov 1992
ReviewIncidence and aetiology of postoperative nausea and vomiting.
The reported incidence of emetic symptoms in surgical patients varies from 8-92%. Intractable postoperative nausea and vomiting remains one of the most unpleasant side-effects experienced by patients postoperatively, both in ambulatory and non-ambulatory care, and has potential risks for severe postoperative complications. Multiple factors are associated with an increased risk of developing postoperative nausea and vomiting: age, gender, pre-existing disease, premedication, operative procedure, anaesthetic and analgesic drugs, anaesthetic procedure, and postoperative symptoms. ⋯ Adequate hydration and pain control should be ensured, tight-fitting oxygen masks avoided, and patients should be encouraged to take slow, deep breaths to decrease the sensation of nausea. To avoid side-effects, anti-emetics should be administered in minimally effective doses. If the administration of anti-emetics is initially unsuccessful, it may be useful to try a combination of anti-emetic drugs with different mechanisms of action.