Articles: nausea.
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Randomized Controlled Trial Multicenter Study Clinical Trial
The efficacy of a combination of ondansetron, methylprednisolone and metopimazine in patients previously uncontrolled with a dual antiemetic treatment in cisplatin-based chemotherapy. The French Ondansetron Study Group.
Cisplatin is one of the most effective cytotoxic drugs used in the treatment of certain neoplasms, but is also one which most frequently induces nausea and vomiting. Combination of corticosteroids with ondansetron enables greater control of emesis than that obtained with ondansetron alone, but some patients still experience symptoms. The objective of this randomised, double-blind, multicentre, parallel group study was to examine the benefit of the addition of metopimazine (MPZ), a dopamine receptor antagonist, to the combination of ondansetron + methylprednisolone (O + M) in the prevention of cisplatin-induced nausea and vomiting in patients uncontrolled [i.e., at least one emetic episode (vomiting and/or retching) or moderate or severe nausea] during their previous course of cisplatin based chemotherapy, despite antiemetic treatment with a combination of a 5-hydroxytryptamine3 receptor antagonist (5HT3) with a corticosteroid. The impact of the treatment on the patients' quality of life was also evaluated using two specific questionnaires the FLIC (Functional Living Index for Cancer), and the FLIE (Functional Living Index for Emesis). ⋯ The study showed that the addition of MPZ to the combination O + M was an effective and well tolerated antiemetic treatment, with a 15% increase in efficacy compared to the combination in patients not controlled during their previous course of chemotherapy. The addition of metopimazine to existing regimens containing 5HT3 receptor antagonist and steroid combination should be considered for patients who fail on their previous course.
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Randomized Controlled Trial Comparative Study Clinical Trial
[Propofol and postoperative nausea and/or vomiting].
The objective of this prospective, randomised study was to investigate the incidence of postoperative nausea and/or vomiting (PONV) during the first 24 h postoperatively. For a quality assurance study on PONV, we compared two established general anaesthetic procedures in 239 patients undergoing four different types of surgery (subtotal thyroidectomy, laparotomy for gynaecological procedures, laparoscopy, and surgery for extra-abdominal procedures). ⋯ We found that the antiemetic effect of propofol was considerable in the early postoperative period. The higher cost of propofol as compared to other induction agents can be covered by not using nitrous oxide for maintenance of anaesthesia and by the decreased need for antiemetic drugs postoperatively. According to the calculations of our clinical pharmacy, the costs of the propofol infusion regimen exceeded those of balanced anaesthesia by 8.50 DM/h; the need for antiemetics was one-half that of the non-propofol group. Considering a cost of 16 DM for cleaning the bed after vomiting, improvement of the patient's condition during the postoperative period can be achieved without additional expense.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A double-blind crossover study comparing prophylactic intravenous granisetron alone or in combination with dexamethasone as antiemetic treatment in controlling nausea and vomiting associated with chemotherapy.
The efficacies of granisetron plus dexamethasone and granisetron alone in controlling nausea and vomiting during two consecutive cycles of moderately emetogenic chemotherapy given for up to 5 days were compared in a two-centre, randomised, double-blind, placebo-controlled crossover study. In all, 110 evaluable patients received either dexamethasone, 20 mg i.v., or matching placebo, plus open-label granisetron, 3 mg i.v., given on each chemotherapy day. At cycle 2, patients crossed over to the alternative treatment; 72 patients completed the crossover. ⋯ Adverse events tended to be minor, with asthenia and insomnia the most common. Of those patients who expressed a preference, 67% preferred granisetron plus dexamethasone (P < 0.05). A single dose of dexamethasone added to granisetron thus enhances the efficacy of granisetron alone in preventing nausea and vomiting after moderately emetogenic chemotherapy.
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Anesthesia and analgesia · Sep 1997
Randomized Controlled Trial Multicenter Study Clinical TrialTreatment of postoperative nausea and vomiting with single intravenous doses of dolasetron mesylate: a multicenter trial. Dolasetron Mesylate PONV Treatment Study Group.
This study was conducted to determine the efficacy and safety of four intravenous (I.V.) doses of dolasetron, an investigational 5-HT3 receptor antagonist, for the treatment of postoperative nausea and/or vomiting (PONV) after outpatient surgery under general anesthesia. This multicenter, randomized, double-blind trial compared the antiemetic efficacy of 12.5, 25, 50, or 100 mg I.V. dolasetron with placebo over 24 h using complete response (no emetic episodes and no rescue medication), time to first emetic episode or rescue medication, and patient nausea and satisfaction with antiemetic therapy as rated by visual analog scale (VAS). Of 1557 patients enrolled, 620 patients were eligible for treatment. Complete response rates for all dolasetron doses--12.5 mg (35%), 25 mg (28%), 50 mg (29%), and 100 mg (29%)--were significantly more effective than placebo (11%, P < 0.05). There was a significant gender interaction for complete response (P < 0.01). Of the patients in the 25-mg and 100-mg dose groups, 12% and 13%, respectively, experienced no nausea (VAS score < 5 mm) versus 5% in the placebo group (P < 0.05). There were no clinically relevant changes in vital signs or laboratory values and no trends with dose for adverse events. Dolasetron is effective for treating PONV and has an adverse event profile similar to that of placebo. The 12.5-mg dose was as effective as larger doses for complete response. ⋯ Nausea and vomiting are common problems for postsurgical patients. In this study of 620 patients undergoing surgery, a 12.5-mg dose of intravenous dolasetron, a new serotonin-receptor blocker, was significantly more effective than placebo in treating established postoperative nausea and vomiting. Dolasetron 12.5 mg was as safe as placebo.
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Randomized Controlled Trial Clinical Trial
Prevention of PONV with granisetron, droperidol and metoclopramide in female patients with history of motion sickness.
Motion sickness is one of the patient-related factors associated with postoperative nausea and vomiting (PONV). This study was undertaken to assess the efficacy of granisetron, droperidol and metoclopramide for preventing PONV in female patients with a history of motion sickness undergoing major gynaecological surgery. ⋯ Granisetron is a better prophylactic antiemetic than droperidol or metoclopramide in female patients with a history of motion sickness undergoing major gynaecological surgery.