Gene/Protein Disease Symptom Drug Enzyme Compound
Pivot Concepts: Gene/Protein Disease Symptom Drug Enzyme Compound   Target Concepts: Gene/Protein Disease Symptom Drug Enzyme Compound

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Query: UMLS:C0027497 (nausea)
23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Three doses of intravenous (i.v.) ondansetron, 1 mg, 4 mg, and 8 mg, were compared to placebo for their antiemetic effect and safety. The drugs or placebo were administered in a double-blind manner, prophylactically to 589 women undergoing elective outpatient surgical procedures under nitrous oxide opioid-based general endotracheal anesthesia. In the postanesthesia care unit, the number of emetic episodes, periodic assessments of nausea severity using an 11-point scale (0 = no nausea; 10 = worst nausea), vital signs, and adverse events were collected by an independent observer for 2 h. Upon discharge, identical information, with the exception of vital signs, was collected from the patients' diary and via phone call. One pre- and two poststudy blood specimens for hematology and chemistries were evaluated. During the initial 2 h, patients receiving any dose of ondansetron had significantly better complete response rates (no emesis) than those receiving placebo. Over the 24-h study period, patients who received either 4 mg or 8 mg ondansetron continued to have significantly greater complete response rates. Adverse events were minor, and ondansetron-treated patients had profiles similar to those of the placebo. Heart rate, blood pressure, respiratory rate, and laboratory safety variables were not different among the groups. Ondansetron did not prolong awakening time. This study indicates that ondansetron is a safe and effective prophylactic antiemetic for women who have outpatient surgery under nitrous oxide opioid-based general anesthesia.
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PMID:Ondansetron prevents postoperative nausea and vomiting in women outpatients. 797 98

Female patients with ovarian cancer are at high risk for emesis. A study evaluating the antiemetic activity and tolerability of ondansetron plus dexamethasone compared to metoclopramide plus dexamethasone plus diphenhydramine in this group of patients has been performed. A group of 63 patients with ovarian cancer undergoing cisplatin treatment were enrolled in the study. Vomiting, nausea and other side-effects were evaluated by the investigators during the first 24 h and recorded by the patients on a diary card on days 2-4. Ondansetron plus dexamethasone showed a higher antiemetic activity during the first 24 h after cisplatin administration in all three cycles of cisplatin treatment, giving over 90% complete protection from vomiting at the first cycle. The efficacy of ondansetron plus dexamethasone decreased at the second cycle, but the percentage of complete protection from vomiting always remained better than 70%; there was poorer protection in the metoclopramide group, and its effect was similar during all three cycles. Ondansetron plus dexamethasone was also found to be more efficacious than the metoclopramide regimen on the second day after cisplatin administration, while on days 3-4 a high rate of complete protection from emesis was achieved by both antiemetic therapies (> 80%). About 40%-55% of patients receiving ondansetron plus dexamethasone and about 65%-85% of patients treated with metoclopramide plus dexamethasone plus diphenhydramine reported nausea or vomiting during days 1-4. Ondansetron plus dexamethasone is more efficacious than metoclopramide plus dexamethasone plus diphenhydramine but new strategies to improve antiemetic efficacy in ovarian cancer patients must be outlined.
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PMID:Ondansetron plus dexamethasone versus metoclopramide plus dexamethasone plus diphenhydramine in cisplatin-treated patients with ovarian cancer. Italian Group for Antiemetic Research. 803 96

Emesis and nausea are common toxicities seen during high-dose interleukin-2 (IL-2) therapy (720,000 IU/kg i.v. every 8 h). A growing list of randomized studies have documented the efficacy of ondansetron, a potent antagonist of the 5-hydroxytryptamine3 receptor, in preventing acute chemotherapy-induced emesis and nausea. However, no study has evaluated the efficacy of ondansetron in preventing IL-2-induced emesis and nausea. This double-blinded, randomized trial was performed to compare the antiemetic and antinausea efficacy of ondansetron with that of droperidol, a butyrophenone, in patients receiving high-dose IL-2 on protocols at the National Cancer Institute. Ondansetron or droperidol was given intravenously, 30 min prior to the first dose of IL-2 and then every 8 h for the duration of IL-2 treatment. No significant differences were seen between the two agents in complete freedom from emesis (p2 = 0.51), level of nausea (p2 = 0.17), antiemetic treatment failure (p2 = 0.89), and time to first emetic episode (p2 = 0.44). Equivalent doses of IL-2 were administered on each arm of the study, with a similar incidence of liver dysfunction (p2 = 0.15) and diarrhea (p2 = 0.64). Finally, there was no significant difference in the response rates to metastatic disease in either arm of the antiemetic study (p2 = 0.67), and these response rates were similar to those in other patients treated under immunotherapy protocols in the Surgery Branch of the National Cancer Institute with high-dose IL-2. We conclude that droperidol is equally effective in preventing emesis and controlling nausea when compared with ondansetron for patients receiving high-dose IL-2.
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PMID:A randomized double-blinded comparison of the antiemetic efficacy of ondansetron and droperidol in patients receiving high-dose interleukin-2. 808 60

In two placebo-controlled, double-blind, multicentre studies, the efficacy and safety of single oral doses of ondansetron 4 mg, 8 mg and 16 mg were evaluated for the prevention of postoperative nausea and vomiting in female inpatients. For the total study populations, 26% (European study) and 32% (US study) of placebo-treated patients experienced no emesis compared with 54% (European study) and 52% (US study) of patients treated with ondansetron 16 mg, the most effective dose. Similarly, 22% (European study) and 19% (US study) of placebo-treated patients experienced no nausea compared with 42% (European study) and 34% (US study) of ondansetron 16 mg-treated patients. All ondansetron doses in both studies were statistically superior to placebo (emesis p < or = 0.007; nausea p < or = 0.033). Slightly lower percentage differences in complete response between placebo and ondansetron for both nausea and emesis were observed for patients with a previous history of postoperative nausea and emesis compared with patients with no previous history, with ondansetron 16 mg being the most effective dose for both patient groups. In the US study, a slightly greater percentage of patients undergoing non-gynaecological surgery had no nausea and no emesis compared with patients undergoing gynaecological surgery in both the placebo and ondansetron treatment groups. Again, ondansetron 16 mg was the most effective dose in both surgery types. Ondansetron was well tolerated, with only headache being reported as a significant problem in both studies.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Single oral dose ondansetron in the prevention of postoperative nausea and emesis. The European and US Study Groups. 812 57

Postoperative nausea and vomiting is a major concern for patients undergoing outpatient surgery under general anaesthesia, and may complicate and delay discharge from hospital. This paper evaluates the safety and efficacy of ondansetron, a 5-HT3 receptor antagonist, in the treatment of postoperative nausea and vomiting. One thousand patients in 30 centres in the United States who received general anaesthesia and developed postoperative nausea and vomiting were studied. In a randomised, double-blind, stratified and parallel designed protocol, patients received either ondansetron 1, 4, 8 mg or placebo for nausea or vomiting occurring within 2 h of entry into the Post Anaesthesia Care Unit. Subsequent episodes of vomiting, nausea scores, laboratory and clinical safety data and adverse events were evaluated during the 24-h study period. In a separate study, pharmacokinetic data were compared for intramuscularly and intravenously administered ondansetron. Each dose of ondansetron was significantly better than placebo in reducing nausea from control values during the initial 2-h study period, and in preventing further emesis over 24 h. There were no significant differences in the incidence of adverse events, changes in laboratory values or measures of vital signs in the ondansetron groups compared to the placebo group. Dose comparisons between the three treatment groups showed that ondansetron 4 mg is the optimal dose to treat postoperative nausea and vomiting. Ondansetron is a well tolerated, efficacious antiemetic which has a similar side effect profile to placebo. Intramuscular administration has the same systemic availability as intravenous administration.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Single dose intravenous ondansetron for the 24-hour treatment of postoperative nausea and vomiting. 812 59

Ondansetron, a selective 5-HT3 antagonist, has been shown to be effective in preventing chemotherapy-induced nausea and vomiting. From July and August 1991, 25 patients were accrued in a phase II study to assess the efficacy of ondansetron in patients receiving cisplatin-containing chemotherapy. Patients received intravenous cisplatin 100 mg/m2, given either as a 24-hour infusion on day 1 or in divided doses as eight-hour infusions daily on days 1 to 3. Each patient received 24 mg of ondansetron per day for six days. Intravenous dexamethasone 24 mg was given daily on the days of cisplatin infusion. The emetic episodes and degree of nausea were evaluated daily. "Good" control of emesis (0-2 episodes of vomiting) and nausea (mild or no nausea) ranged from 64-100% and 88-100% respectively. Failure in emesis control occurred most frequently on days 3 and 4. Ondansetron was generally well tolerated with only minimal side-effects. One patient developed unexplained encephalopathy which resolved completely. Our results suggest that ondansetron is an effective anti-emetic agent with minimal toxicities. Randomised studies comparing ondansetron against "standard" anti-emetics should be conducted.
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PMID:Use of oral and intravenous ondansetron in patients treated with cisplatin. 812 53

One-hundred and forty-five chemotherapy patients receiving cisplatin- and non-cisplatin-containing regimens participated in an open evaluation of ondansetron, a 5-HT3 receptor antagonist, in the prophylaxis of acute and delayed nausea and vomiting. The study had two groups of patients, one receiving cisplatin-containing regimens (Group A) and the other, non-cisplatin-containing regimens (Group B). There were 51 patients recruited to Group A. Ondansetron was given to these patients at a dose of 8 mg intravenously 15 min before chemotherapy, followed by an intravenous infusion for 24 h (1 mg/h), or 8 mg intravenously 4 and 8 h after the start of cisplatin, followed by 8 mg orally three times/day for 5 days. Ninety-four patients were recruited to Group B: these patients received ondansetron at a dose of 8 mg intravenously immediately before chemotherapy or 8 mg orally 1-2 h prior to it, and 8 mg orally three times/day for 3-5 days. For acute emesis (first 24 h), complete control was achieved in 79.5% of Group A patients and in 78.1% of Group B. For delayed emesis (days 2-5), 79.7% of Group A patients and 84.6% of Group B were completely protected during the entire study period. Nausea was also well controlled with ondansetron; 83.2% (Group A) and 86.5% (Group B) reported only mild nausea or no nausea at all. Ondansetron was effective in the control of both cisplatin- and non-cisplatin-induced emesis and well tolerated without any serious drug-related adverse events.
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PMID:Ondansetron in the treatment of nausea and vomiting induced by chemotherapy. Portuguese Ondansetron Study Group. 813 12

We studied the efficacy and safety of intravenous ondansetron 4 mg for the prevention of postoperative nausea and vomiting after minor gynaecological laparoscopic surgery in Oriental women. This double-blind randomised study compared ondansetron with placebo, given before the induction of anaesthesia. The anaesthetic technique used thiopentone, fentanyl, atracurium, nitrous oxide and isoflurane. Patients were studied for 24 h with nausea assessed using a verbal numeric scale from 0-10 and emetic episodes recorded as they occurred. Results were available for 102 patients in each group. In the first postoperative hour, fewer patients in the ondansetron Group (12%) had emetic episodes compared with the placebo group (33%, P < 0.01). Nausea score over the first hour (sum of three readings at 0, 30 and 60 min) was lower in the ondansetron group (median 1.6) compared with the placebo group (3.1, P < 0.05). Over the 24 h period, fewer patients in the ondansetron group had emetic episodes (25%) or nausea (43%) compared with patients in the placebo group (56%, P < 0.01) and (58%, P < 0.05) respectively. No adverse events were seen. Ondansetron 4 mg was more effective than placebo in preventing postoperative nausea and vomiting throughout the 24 h after minor laparoscopic surgery.
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PMID:Ondansetron 4 mg for the prevention of nausea and vomiting after minor laparoscopic gynaecological surgery. 821 15

A total of 1442 patients who had major gynaecological surgery were recruited into three multicentre studies using a standard general anaesthetic technique in order to assess the efficacy of various doses of orally administered ondansetron in the prevention of postoperative nausea and vomiting. A total of 1257 patients were included in this analysis: 420 received oral formulations of placebo and 212, 296 and 329 received ondansetron 1, 8 and 16 mg, respectively. The following factors were measured in these studies and were considered to have a possible influence on the proportion of patients experiencing postoperative nausea and vomiting: age of patient; volatile anaesthetic; intraoperative dose of fentanyl; postoperative dose of morphine; country; anaesthesia duration; neuromuscular blocker; neuromuscular block antagonist; premedicant; recovery time; type of surgery; antiemetic treatment; body weight. Using a process of elimination based on logistic regression techniques, the factors found to be the most important influences on the frequencies of nausea and vomiting were antiemetic treatment, type of surgery, neuromuscular blocker, country, volatile anaesthetic and age. A statistically significant interaction between type of surgery and age was observed. Adjusted probabilities of nausea and vomiting were obtained from the model, including all the above factors, together with the type of surgery by age interaction. Ondansetron 8 mg showed the smallest adjusted probability of nausea (0.54) and vomiting (0.34) and placebo the greatest (nausea 0.75, vomiting 0.61). A similar pattern of adjusted probabilities over neuromuscular blocking agents was seen for nausea and vomiting, with the greatest occurring in patients receiving pancuronium (nausea 0.74, vomiting 0.57) and the least in patients receiving alcuronium (nausea 0.59, vomiting 0.38).(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Nausea and vomiting after gynaecological surgery: a meta-analysis of factors affecting their incidence. 826 Mar

Ondansetron, a selective 5-HT3 antagonist, is known to be effective for preventing emesis induced by cisplatin and other antineoplastic agents. We undertook a randomized double-blind study in a series of bone marrow transplantation (BMT) recipients to assess the antiemetic efficacy and the safety of ondansetron in comparison with chlorpromazine, which was being used at our institution, as the standard antiemetic agent for the conditioning regimen. Forty patients submitted to BMT (21 autologous, 19 allogeneic) were included in the study. Patients were randomly assigned to receive ondansetron (as a loading dose of 8 mg iv one hour before the beginning of the conditioning regimen followed by a continuous infusion of 1 mg per hour for the whole treatment period) or chlorpromazine 60 mg/m2/day given by continuous infusion for the same period (maximum 8 days). Twenty patients were assigned to ondansetron, while 20 were assigned to chlorpromazine. The response rate in terms of antiemetic efficacy and in nausea control was similar between the two treatment groups. On the contrary the two groups differed significantly in regard to side-effects: patients receiving ondansetron experienced significantly less sedation (p = 0.002), the absence of extrapyramidal reactions (p < 0.001) and no need for dose reduction (p < 0.001) as compared with patients treated with chlorpromazine.
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PMID:Ondansetron versus chlorpromazine for preventing emesis in bone marrow transplant recipients: a double-blind randomized study. 837 Nov 29


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