Tropisetron or ondansetron compared with placebo for prevention of postoperative nausea and vomiting

In a prospective, randomized, double-blind, placebo-controlled, multicentre study, the efficacy of prophylactic tropisetron (2 mg) or ondansetron (4 mg) for the prevention of post-operative nausea and vomiting after abdominal or non-abdominal surgery with general balanced anaesthesia was studied in 842 ASA I-III patients. In patients undergoing abdominal surgery, ondansetron and tropisetron reduced the frequency of emetic episodes compared with the placebo (29%, 30% vs. 42% respectively). In men, neither tropisetron nor ondansetron had an effect different from the placebo, whereas in women both drugs led to lower rates of emetic episodes and nausea. In comparison with abdominal surgery, fewer patients in the non-abdominal surgery subgroup had emetic episodes (42% vs. 23% in the placebo group). However, neither tropisetron nor ondansetron was significantly different from the placebo in this patient subgroup. In conclusion, for patients at increased risk of post-operative nausea and vomiting, a prophylactic therapy at the lowest effective dose with tropisetron or ondansetron may be useful.     

Continuous-infusion granisetron compared to ondansetron for the prevention of nausea and vomiting after high-dose chemotherapy

OBJECTIVES: The main aim was to calculate the prevalence of mental pathology in women between 18 and 70 in a Health District of Pamplona; second, to describe comorbidity and to analyse how mental pathology was recorded in the clinical histories. DESIGN: An observational crossover study with randomised selection. SETTING: A community study in the Txantrea quarter of Pamplona, covering 21,590 inhabitants, with 7605 women between 18 and 70. PATIENTS: Randomised sample, stratified by age, of 237 women between 18 and 70 taken from the 1991 Census. MEASUREMENTS AND RESULTS: In a face-to-face interview at the Health Centre, the DIS Questionnaire, which diagnoses mental illness, was administered to all participants. A check was made to see if mental pathology was recorded in their clinical history. The prevalence of mental illnesses, mainly Phobias and Depression, in the "last year of life" was 33.3% (27.5-39.5), which fell to 24.9% (19.7-30.7) when tobacco abuse was excluded. The most common pathologies were: Depression (17.3%), Tobacco dependency (17.3%), simple Phobia (14.8%), Agoraphobia (13.5%), social Phobia (8.9%) and post-traumatic stress (8.0%). CONCLUSIONS: Understanding the high psychological morbidity in these urban women can contribute to the development of Mental Health Promotion and Prevention Programmes and foment fuller mental health training for Primary Care professionals.     

Comparison of single-dose oral granisetron versus intravenous ondansetron in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy: a multicenter, double-blind, randomized parallel study

PURPOSE: The antiemetic effectiveness and safety of single-dose oral granisetron were compared with intravenous (I.V.) ondansetron in chemotherapy-naive patients who received moderately emetogenic chemotherapy. PATIENTS AND METHODS: In this double-blind, parallel-group study, patients naive to emetogenic chemotherapy (N = 1,085) who were scheduled to receive cyclophosphamide- (500 to 1,200 mg/m2) or carboplatin (> or = 300 mg/m2) based chemotherapy, were randomized to receive either oral granisetron (n = 542) or I.V. ondansetron (n = 543). Efficacy assessments included the proportion of patients in each treatment group with total control over the 24 and 48 hours following chemotherapy initiation, as well as incidence and severity of nausea and emesis and use of antiemetic rescue medication. Prophylactic corticosteroids were allowed. Safety assessment was based on patients' reports of adverse experiences. RESULTS: Approximately 80% of patients received prophylactic corticosteroids. Single-dose oral granisetron (2 mg) and I.V. ondansetron (32 mg) resulted in equivalent levels of total emetic control during the first 48 hours after chemotherapy. The proportion of nausea- and emesis-free patients at 24 and 48 hours were also approximately equivalent. The most commonly reported adverse experiences were headache, asthenia, and constipation. More patients who received ondonsetron than granisetron reported dizziness (9.6% v 5.4%, respectively; P = .011) and abnormal vision (4.2% v 0.6%, respectively; P < .001). CONCLUSION: A single oral dose of granisetron (2 mg) resulted in equivalent levels of antiemetic protection as I.V. ondansetron (32 mg). Both agents were well tolerated, although more dizziness and abnormal vision were reported with ondansetron. Because the two antiemetic regimens exhibited equivalent efficacies, additional factors such as convenience and cost of therapy should be considered.     

Control of nausea and vomiting with ondansetron in patients treated with intensive non-cisplatin chemotherapy for acute myeloid leukaemia

18 consecutive patients with acute myeloid leukaemia (AML) treated with 34 cycles of intensive chemotherapy received ondansetron as antiemetic treatment. 14 patients were chemotherapy-naive, while 4 patients were treated for relapsed leukaemia. All patients received at least one cycle of chemotherapy, 11 patients (61%) received two cycles and 5 patients (28%) received three cycles. The remission induction regimen consisted of cytarabine 200 mg/m2 daily from day 1 to day 7, in combination with an anthracycline or amsacrine on 3 days. During the second and third cycle the dose of cytarabine was increased. Ondansetron was administered as follows: 8 mg intravenously before the start of chemotherapy, followed by 8 mg orally three times daily for 10 days. 50% of patients had no episodes of vomiting during the first cycle of chemotherapy and 78% had less than five episodes of vomiting over 10 days. 72% of patients had no or only mild nausea. These high response rates were maintained during the subsequent cycles. No side-effects due to ondansetron were registered. These data indicate that ondansetron is efficacious in preventing nausea and vomiting in patients with AML treated with intensive chemotherapy.     

Sensitizing effects of pretreatment measures on cancer chemotherapy nausea and vomiting.

This study explored the sensitizing effects of pretreatment assessment on posttreatment chemotherapy nausea and vomiting and the interactive effects of personal dispositions for information seeking. Seventy oncology outpatients were recruited from oncology waiting rooms prior to receiving scheduled chemotherapy. Half of the patients were asked to complete an inventory about the severity of side effects that they had experienced following their most recent treatment session (experimental condition) and half were asked to complete an inventory concerning parking conditions at the treatment facility (control condition). All patients were also asked to complete the Miller Behavioral Style Scale (MBSS) and to later rate the severity of their side effects (between 36–48 hr following treatment). Based on the MBSS scores, patients were then divided into information seekers (monitors) and information avoiders (blunters). Overall, patients in the experimental condition rated the severity of their nausea as more severe than the control patients. In addition, patients who preferred a monitoring coping style experienced a significantly higher incidence rate and longer episodes of nausea than patients who preferred a blunting style. The methodological implications of these results for data collection and the assessment of side effects associated with aversive medical procedures are discussed. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

A randomized trial of tropisetron in the prophylaxis of nausea and vomiting induced by chemotherapy

Thirty patients receiving cisplation or non-cisplatin (containing cyclophosphamide and adriamycin) chemotherapy were enrolled in a randomized, crossover study comparing the efficacy of single dose of Navoban (tropisetron, 5 mg) and Kytril (granisetron, 3 mg). The effective control of acute vomiting induced by cisplatin was achieved in 95.2% (20/21) of patients receiving Navoban and 90.5% (19/21) in those receiving Kytril. Complele control rate was 71.4% (15/21) in Navoban arm, and 81.0% (17/21) in Kytril arm. Total control of delayed vomiting (day 2-5) was 71.4%-90.4% in Navoban arm, while it was 66.7%-4% in Kytril arm. The effective control of vomiting induced by non-cisplatin drugs was achieved in 9/9 in both arms. It is concluded that both agents are effective in the control of vomiting induced by chemotherapy. They have identical adverse effects and are well tolerated by the patients.     

Levonantradol, a new antiemetic with a high rate of side-effects for the prevention of nausea and vomiting in patients receiving cancer chemotherapy

Levonantradol, a new antiemetic compound pharmacologically related to the cannabinoids, was given to 17 patients who had experienced severe and protracted nausea and vomiting during previous courses of cancer chemotherapy, and to six patients receiving a first course of strongly emetic cytostatic treatment. Eight patients were partially protected from acute gastrointestinal disturbances. Of the 23 patients, 21 exhibited some toxicity, with six patients exhibiting major affective side-effects and 13 patients complaining of pain at the injection site. Levonantradol is an active antiemetic compound. Due to the rate of side-effects observed in our study however, we would not recommend use of this agent as an antiemetic drug.     

Intravenous dolasetron mesilate in the prevention of postoperative nausea and vomiting in females undergoing gynecological surgery

STUDY OBJECTIVE: To evaluate a range of doses of intravenous (i.v.) dolasetron mesilate, in preventing postoperative nausea and vomiting (PONV). DESIGN: Double-blind, placebo-controlled, randomized, multicenter trial. SETTING: Ten hospitals and/or surgical centers. PATIENTS: 281 women undergoing gynecologic surgery with general anesthesia. INTERVENTIONS: Patients received one of four single, i.v. doses of dolasetron mesilate (12.5 mg, 25 mg, 50 mg, and 100 mg) or placebo administered following cessation of anesthesia. MEASUREMENTS AND MAIN RESULTS: Patients were monitored for 24 hours following study drug administration. The antiemetic efficacy of each dolasetron mesilate dose was evaluated by recording the number and timing of emetic episodes, and the effects on nausea were assessed by use of visual analog scales (VAS). Safety was assessed by adverse event reports, clinical laboratory tests, electrocardiographic (ECG) measurements, and monitoring vital signs. Complete responses (patients with no emetic episodes and no escape antiemetic medication requirements in 24 hours) were achieved by 54% in the 12.5-mg, 67% in the 25-mg, and 59% in both the 50-mg and 100-mg dolasetron mesilate dose groups, and by 43% in the placebo group. Nausea VAS assessments demonstrated that dolasetron-treated patients were significantly (p = 0.048) more likely to report no nausea (VAS score < 5 mm) than those in the placebo group. Adverse events reported generally were mild in intensity, and there were no clinically significant changes in laboratory tests, vital signs, or ECG parameters. CONCLUSIONS: Dolasetron was effective and well tolerated for the prevention of PONV in female patients undergoing gynecologic surgery with general anesthesia.     

Management of nausea and vomiting in children

When children experience nausea and vomiting (N/V) as side effects of anesthesia or chemotherapy, a major role for nurses is to promote comfort. In addition to the discomfort of N/V in children, other detrimental effects include dehydration, weight loss, fluid and electrolyte imbalance, and emotional distress. This article describes the physiological pathways through which the vomiting center is stimulated to cause nausea and vomiting and identifies appropriate interventions for blocking these pathways using both pharmacological and nonpharmacological means. Medications used to control nausea and vomiting, including phenothiazines, substituted benzamide, corticosteroids, benzodiazepines, antihistamines, and serotonin antagonists, are discussed. Nonpharmacological interventions that are described include reducing anxiety, music therapy, hypnosis, progressive muscle relaxation, dietary modifications, and acupressure.     

Effects of an anti-emetic tropisetron capsule on QOL of patients with delayed nausea and vomiting induced by cancer chemotherapy. Group for Investigation of QOL Questionnaire for Anti-Emetics used in Cancer Chemotherapy. Joint Research Group for Tropisetron Double-Blind Comparative Study

We have reported our "new questionnaire of QOL (quality of life) in anti-emetic therapies during cancer chemotherapy" and demonstrated its reliability and validity. In the present study we investigated the utility of tropisetron capsules for delayed nausea and vomiting induced by cancer chemotherapies with CDDP single administration in a placebo-controlled double-blind comparative study using the questionnaire. The questionnaire was composed of the following scales: a physiological scale (appetite, feeling, vomiting, nausea), a psychological scale (sleep, mental fatigue, anxiety, pain, abdominal condition), a respiratory condition related scale (sputum, respiratory distress), an active scale (daily life in a hospital), a social relation scale (understanding of the family), a linear analogue scale for evaluation of the influence of nausea and vomiting in patient's life during 24 hours, and a face scale as the global scale. First, all patients were administered a preventive dose of tropisetron capsule on day 1 (the day of CDDP administration) and then allotted to once-daily oral administration of either a tropisetron (T group) or a placebo (P group) capsule during days 2 to 5 by a double-blind method. Chronological changes of QOL during the study period were measured by the area under the curve (AUC) generally used for calculation of blood levels of drugs. The maximum fluctuation (Difmax) of QOL scores throughout the whole study period was also evaluated. The data were collected from 114 cases, and 98 cases (51 in P group, 47 in T group) were analyzed. 1) The total score or 13 items (a modified linear analogue scale with 5 graduations), the face scale and linear analogue scale of T group were higher (better) than those of P group. 2) As for the total score of each scale, the physiological, psychological and active scales in the T group showed higher (better) levels than the P group. 3) As for the AUC values, the T group was lower (better) than the P group in most items. In AUC of the total score of 13 items, the face scale, the physiological and the psychological scales, the T group was significantly superior to the P group. 4) AUC levels of each item belonged to the physiological and the psychological scales in the T group tended to be lower (better) than the P group, and "sleep" and "pain" in the psychological scale were significantly lower (better) in T group than P group. 5) In Difmax values, all scales except respiratory condition related scale showed lower levels (better) in T group and the total score of 13 items, the face scale and the physiological and psychological scales showed significantly lower levels than P group. 6) Difmax values in each item belonging to the physiological and psychological scales showed lower levels in the T group, while "appetite" and "vomiting" in the physiological scale and "sleep" in the psychological scale showed significantly lower levels (better) than those of the P group. 7) In the stratified analysis performed for patients without nausea and vomiting on the 1st day of chemotherapy, there was no significance in AUC levels of all items in both groups. In patients with nausea and vomiting on the 1st day, the total score of 13 items, the face scale, the physiological and the psychological scales in the T group were significantly better than in the P group. 8) It was suggested that the anti-emetic efficacy of tropisetron for delayed nausea and vomiting might reduce the undesirable influence of chemotherapy on QOL, especially on the physiological and the psychological effects. These results suggested that this new questionnaire is applicable for evaluation of the utility of anti-emetics in patients in cancer chemotherapy, and that tropisetron capsules could reduce the decrease of QOL in delayed nausea and vomiting induced by chemotherapy.     

A comparison of ranitidine, droperidol or placebo in the prevention of nausea and vomiting after hysterectomy

Surgical procedures including the extent of systematic lymphadenectomy are still under discussion in the treatment of esophageal cancer. In the own patients' population 92 subtotal en bloc-esophagectomies with a standard two field lymphadenectomy were performed. A total of 1483 lymph nodes were resected in the thoracic and abdominal compartments with an incidence of 16.1% being metastatic. Stage pN1 disease occurred in 57.6% of the patients. The median number of lymph nodes resected in each specimen was 16, independent of tumor stage, -site or R-classification. The number of infiltrated nodes increased with tumor stages. R-classification, tumor stage and number of involved lymph nodes could be analyzed as prognostic factors. After R0-resection a median survival rate of 25.4 months could be achieved, following pN0-stage that of 27.4 months. In case of two metastatic lymph nodes the prognosis decreased significantly to 14.4 months (p < 0.01). Therefore, two field lymphadenectomy may show a therapeutic benefit only in a subgroup of patients with a limited number of lymph nodes infiltrated.     

Personality factors associated with anticipatory nausea/vomiting in patients receiving cancer chemotherapy.

100 cancer chemotherapy patients were interviewed, rated the severity of pre- and posttreatment nausea and emesis, and completed the State-Trait Anxiety Inventory. In addition, scores on the Millon Behavioral Health Inventory were obtained for 59 Ss. 33% of the Ss reported having experienced anticipatory nausea, and 11% reported having experienced anticipatory vomiting. Ss who experienced anticipatory nausea had more posttreatment nausea and vomiting, were more depressed, and were characteristically more anxious than other Ss. Future despair, social alienation, inhibited personality style, gastrointestinal susceptibility, chronic tension, and confident personality style were variables that best distinguished Ss who experienced anticipatory nausea. (29 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Ketorolac and propofol administration for prevention of nausea and vomiting in patients undergoing minor gynecologic surgery

This clinical review explores the efficacy of the nonsteroidal antiinflammatory agent, ketorolac tromethamine, added to an anesthetic regimen utilizing intravenous propofol. Both agents have been shown to reduce the incidence of nausea and vomiting postoperatively when administered to patients undergoing minor gynecologic surgery. Because the incidence of nausea and vomiting is significantly reduced when ketorolac is used in place of opioids to attenuate postoperative pain, it would appear to be an appropriate choice of agent to use following propofol anesthesia. The use of this combination of drugs may not only reduce the incidence of postoperative nausea and vomiting in patients undergoing minor gynecologic surgery, but could reduce the duration of hospitalization and enhance recovery from anesthesia.     

Behavioral treatment of chemotherapy-induced nausea and vomiting

Nausea and vomiting associated with chemotherapy most commonly occur after administration of the drug regimen, but a substantial proportion of patients also develop these symptoms in anticipation of treatment, after one or more courses of chemotherapy have been given. Currently available pharmacologic agents are unable to provide complete protection from either anticipatory or post-treatment nausea and emesis associated with cancer chemotherapy. Since anticipatory nausea and vomiting are believed to become conditioned responses through the learning process of classical conditioning, behavioral treatments may be particularly appropriate. Progressive muscle relaxation training is effective in preventing as well as decreasing the frequency of postchemotherapy nausea and vomiting, whereas systematic desensitization has been found to be more effective against anticipatory nausea and emesis. Hypnosis and cognitive distraction have been used mainly in children and adolescents.     

Comparison of three tropisetron-containing antiemetic regimens in the prophylaxis of acute and delayed chemotherapy-induced emesis and nausea

The effects of methoctramine, a cardioselective muscarinic cholinergic antagonist, on heart rate and small intestinal motor activity were compared to those of the nonselective competitive muscarinic antagonist, atropine. Methoctramine or atropine, 6, 10, 30, 60 micrograms/kg, or sterile isotonic saline, was administered intravenously to six conscious dogs in cross-over studies. Methoctramine administration caused dose-dependent tachycardia without affecting intestinal motility, while atropine administration caused dose-dependent tachycardia accompanied by significant reductions in small intestinal motility. Additionally, methoctramine did not inhibit intestinal smooth muscle contractile activity initiated by the muscarinic agonist bethanechol, while atropine inhibited bethanechol-induced contractile activity in a dose-dependent manner. Calculated, dosages of methoctramine and atropine required to produce a 50% increase in heart rate over baseline were 35.1 +/- 5.3 and 39.5 +/- 6.2 micrograms/kg, respectively. This dosage of atropine caused a 93 +/- 13.9% reduction in intestinal motility. These findings suggest that selective muscarinic antagonists may be useful drugs for those veterinary patients in which nonselective muscarinic antagonists have the potential to produce untoward effects on intestinal motility.     

Intravenous dolasetron and ondansetron in prevention of postoperative nausea and vomiting: a multicenter, double-blind, placebo-controlled study

BACKGROUND: Intravenous dolasetron mesilate has shown efficacy in the prevention of postoperative nausea and vomiting (PONV) when administered as a single dose prior to emergence from anesthesia. This trial compared intravenous dolasetron and ondansetron for the prevention of PONV when administered at induction of anesthesia. METHODS: This double-blind, placebo-controlled, multicenter trial randomized patients to one of four single IV treatments placebo, 25 or 50 mg dolasetron, or 4 mg ondansetron. Efficacy was measured by complete response (0 emetic episodes and no rescue medication), nausea severity and patient satisfaction as measured on a visual analog scale (VAS), investigator's rating, of nausea severity, and total response (complete response with no nausea [< or = 5 mm VAS]). RESULTS: 514 patients at 24 sites were evaluated for efficacy. The 50 mg dolasetron and 4 mg ondansetron doses were statistically equivalent, and superior to placebo, for all efficacy measures. Complete response rates were 49%, 51%, 71% and 64% for placebo, 25 and 50 mg dolasetron, and ondansetron, respectively. Dolasetron 50 mg was statistically superior to 25 mg dolasetron for complete response, total response, VAS maximum nausea, time to first emetic episode, and patient satisfaction. The majority of adverse events were of mild-to-moderate intensity. Headache was the most frequently reported treatment-related adverse event with a 3%-5% incidence across treatments. CONCLUSION: When given at induction of anesthesia, 50 mg intravenous dolasetron is equivalent to 4 mg ondansetron and superior to 25 mg dolasetron and placebo for the prevention of PONV. All treatments were safely administered and well tolerated.     

Ondansetron for prevention of postoperative nausea and vomiting following minor oral surgery: a double-blind randomized study

The efficacy and safety of ondansetron in preventing postoperative nausea and vomiting following minor oral surgery was evaluated in a prospective randomized double-blind study. Of a total of seventy-seven patients, randomly 38 had 4 mg of ondansetron and 39 had normal saline as placebo intravenously immediately prior to induction of anaesthesia. A standard general anaesthetic with thiopentone, suxamethonium, fentanyl, nitrous oxide and isoflurane was employed. Postoperatively nausea was assessed verbally and on a visual analog scale at 1, 4 and 24 hours from the time of awakening. Episodes of vomiting were recorded. Eight patients (21.1%) in the ondansetron group compared to 19 (48.7%) in the placebo group had nausea (P < 0.05) and 1 (2.6%) in the ondansetron group compared with 9 (23.1%) in the placebo group vomited (P < 0.05). Patients who vomited twice or more and the number who required a rescue antiemetic were significantly fewer in the ondansetron group (P < 0.05). Cardiovascular parameters were stable and showed no significant difference in the two groups. There were no significant adverse effects that could be directly attributable to ondansetron.     

Anticipatory nausea and vomiting in the era of 5-HT3 antiemetics

Variegate porphyria (VP) is an autosomal dominant disorder characterised by a partial defect in the activity of protoporphyrinogen oxidase (PPO), and has recently been genetically linked to the PPO gene on chromosome 1q22-23 (Z=6.62). In this study, we identified a mutation in the PPO gene in a patient with VP and two unaffected family members. The mutation consisted of a previously unreported T to C transition in exon 13 of the PPO gene, resulting in the substitution of a polar serine by a non-polar proline (S450P). This serine residue is evolutionarily highly conserved in man, mouse, and Bacillus subtilis, attesting to the importance of this residue. Interestingly, the gene for Gardner's syndrome (FAP) also segregates in this family, independently of the VP mutation. Gardner's syndrome or familial adenomatous polyposis (FAP) is also an autosomal dominantly inherited genodermatosis, and typically presents with colorectal cancer in early adult life secondary to extensive adenomatous polyps of the colon. The specific gene on chromosome 5 that is the site of the mutation in this disorder is known as APC (adenomatous polyposis coli), and the gene has been genetically linked to the region of 5q22.