European journal of anaesthesiology. Supplement
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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.
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Eur J Anaesthesiol Suppl · Jan 1992
Multicenter Study Clinical TrialHaemodynamic and biological effects of intravenous milrinone in patients with a low cardiac output syndrome following cardiac surgery: multicentre study.
The haemodynamic and biological effects of intravenous milrinone were studied in 24 adult patients with a low cardiac output syndrome following cardiac surgery. The patients received a milrinone bolus of 50 micrograms kg-1 over 10 min followed by a 0.375-0.750 micrograms kg-1 min-1 infusion over 48 h. ⋯ These haemodynamic effects were maintained over the 48 h of treatment and persisted 3 h after discontinuation of treatment. Milrinone, which possesses inotropic and vasodilatory effects, increased cardiac performance and corrected the low cardiac output in all patients.
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Eur J Anaesthesiol Suppl · Jan 1992
Multicenter Study Clinical Trial Controlled Clinical TrialMilrinone and the pulmonary vascular system.
In a multicentre study of 99 adult patients undergoing cardiac surgery, if post-operative cardiac failure was demonstrated (pulmonary capillary wedge pressure greater than 8 mmHg, cardiac index less than 2.5 litre min-1 m-2), then a bolus dose of milrinone (50 micrograms kg-1) was given, followed by an infusion at one of three rates (0.375, 0.5 or 0.75 microgram kg-1 min-1), and haemodynamic effects were assessed. Mean pulmonary artery pressures fell by 15% initially (P less than 0.001), and this significant reduction was maintained throughout the infusion period and reversed with the withdrawal of milrinone. Mean pulmonary vascular resistance fell progressively throughout the infusion period, the maximum change (30-40%) being evident at the 12 h point (P less than 0.05). ⋯ There was a significant reduction in pulmonary vascular resistance and increase in cardiac index in all patients. At the 15 min point, there was significant between-group variation, the fall in pulmonary vascular resistance and increase in cardiac index being greater in Group 1 than in Groups 2 or 3. This difference between groups was not maintained during the infusion.