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
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 · Jan 1992
Multicenter Study Clinical Trial Controlled Clinical TrialMilrinone in the treatment of low output states following cardiac surgery.
Milrinone is known to have beneficial haemodynamic and clinical effects in patients with congestive heart failure. An investigation into the safety and efficacy of milrinone in patients following heart surgery was undertaken by the European Milrinone Multicentre Trial Group. This paper reports the efficacy, the effects on left heart function, and the adverse events in the study. ⋯ At 15 min and 60 min there was a dose-related decrease in systolic and diastolic arterial pressure; however, there was no significant difference in the mean arterial pressure measurements. In all groups there was an improvement in cardiac index at 15 min following the start of milrinone, which was sustained during and up to 4 h after the infusion. This was closely associated with changes in stroke volume index and systemic vascular resistance, and not solely due to a change in heart rate.
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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.