Articles: nausea.
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Randomized Controlled Trial Multicenter Study Clinical Trial
A single i.v. dose of ondansetron 8 mg prior to induction of anaesthesia reduces postoperative nausea and vomiting in gynaecological patients.
The effect of a single intravenous dose of ondansetron in preventing postoperative nausea and emesis (retching and vomiting) (PONV) was investigated in a randomized, double-blind, placebo-controlled, multicentre, international study. Women of ASA class I-III, requiring gynaecological laparotomy, vaginal hysterectomy, or major vaginal surgery were selected for study. Two hundred and thirty-five received placebo, 231 received 1 mg ondansetron, 228 received 8 mg ondansetron and 229 received 16 mg ondansetron, as an infusion over five minutes before the induction of anaesthesia. ⋯ Postoperative analgesia was achieved with morphine, and prochlorperazine or metoclopramide were given if a rescue antiemetic was required. A greater percentage of patients in the 8 mg and 16 mg ondansetron groups experienced no postoperative emesis (44% and 39% respectively) than in the placebo and 1 mg ondansetron groups (29% and 28% respectively) for the first 24 hr postoperative period (8 mg vs placebo and 1 mg: P < or = 0.001; 16 mg vs placebo: P < 0.05; 16 mg vs 1 mg: P < 0.05). Similarly, the percentage of patients who did not experience postoperative nausea were 20%, 26%, 31% and 28% for the placebo, 1 mg, 8 mg and 16 mg ondansetron treatment groups, respectively (8 mg and 16 mg vs placebo P < 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)
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Gan To Kagaku Ryoho · Sep 1993
Multicenter Study Clinical Trial Controlled Clinical Trial[Granisetron oral phase III clinical trial--study on the inhibitory effect of granisetron for nausea/vomiting induced by chemotherapy for tumors in the hematopoietic organs].
The efficacy and safety of oral granisetron against nausea and vomiting induced by chemotherapy for tumors in the hematopoietic organs were investigated. Depending on the day of anticancer drug administration, single administration or 2 to 6-day repeated administration of granisetron at 2 mg once daily was conducted. ⋯ Adverse events which were suspected to be related to granisetron included 1 case of mild feeling of residual urine and another demonstrating very mild eosinophilia. From the above results, it was confirmed that granisetron was a safe and effective antiemetic against nausea and vomiting induced by anticancer drug administration.
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Multicenter Study
Impact of chemotherapy-associated nausea and vomiting on patients' functional status and on costs: survey of five Canadian centres.
To estimate the effect of chemotherapy-associated nausea and emesis on patients' functional status and on costs to the health care system, the patients and society before antagonists to the serotonin (5-hydroxytryptamine) receptor subtype 5-HT3 became available. ⋯ Despite prophylaxis with antiemetic drugs, nausea and emesis were significant problems in this population receiving chemotherapy. The management of emesis consumed relatively small amounts of health care resources, but there were costs outside the hospital for patients and others.
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Gan To Kagaku Ryoho · Aug 1993
Multicenter Study Clinical Trial Controlled Clinical Trial[Study on the inhibitory effect of oral granisetron against nausea/vomiting induced by cytosine arabinoside containing chemotherapy for tumors in the hematopoietic organs].
We investigated the antiemetic effect, safety and usefulness of granisetron tablet on nausea/vomiting induced by cytosine arabinoside (Ara-C) in the chemotherapy for tumors in the hematopoietic organs. Out of 52 cases with malignant tumors in the hematopoietic organs including acute leukemia, 30 in granisetron group had no antiemetic treatment, were evaluated for the clinical efficacy of granisetron and 22 in control group. Their chemotherapies were combination therapy with Ara-C and daunorubicin (DNR), Ara-C and mitoxantrone (MIT), or Ara-C and etoposide (VP-16). ⋯ Granisetron was judged as "Safe" in 31 out of 32 cases (96.9%). In terms of usefulness, the drug was rated "Extremely useful" or "Useful" in 26 out of 30 cases (86.7%). The above results have shown that granisetron tablet, when administered orally once daily at a dose of 2 mg, has an excellent antiemetic effect, and is a safe and useful drug.
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Gan To Kagaku Ryoho · Jul 1993
Multicenter Study Comparative Study Clinical Trial Controlled Clinical Trial[Clinical evaluation of granisetron for nausea and vomiting induced by anticancer drugs--multi-centered placebo-controlled double-blind comparative study].
A placebo-controlled double-blind comparative trial was conducted to objectively assess the antiemetic effect on nausea and vomiting induced by anticancer drugs including cisplatin (CDDP) and safety of granisetron tablet (2 mg). In the present trial, single oral administration of the trial drug was performed one hour before the start of CDDP administration. 1) In clinical efficacy, the drug was assessed as "remarkably effective" or "effective" in 76.9% (30/39) in G group and 15.2% (7/46) in P group. ⋯ S., the dose of CDDP and the number of anticancer drugs concomitantly used with CDDP. 4) The clinical effect of single oral administration of granisetron tablet (2 mg) persisted for approximately 24 hours. 5) In terms of the safety of the trial drug, there was no adverse event or abnormal laboratory fluctuation which might pose a clinical problem. From the above results, it was concluded that single oral administration of granisetron at a dose of 2 mg could suppress nausea and vomiting induced by the administration of anticancer drugs.