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PubMed2006

Postoperative nausea and vomiting and pain after transsphenoidal surgery: a review of 877 patients.

Although postoperative nausea and vomiting and pain after supra- and infratentorial craniotomy have been evaluated in multiple studies, there are few data regarding pain or postoperative nausea and vomiting after transsphenoidal procedures. Therefore, we reviewed the perioperative records of 877 patients undergoing transsphenoidal surgery by the same surgeon. The overall incidence of postoperative emesis was 7.5%, significantly less than most studies of neurosurgical patients. An intraoperative cerebrospinal fluid leak and subsequent fat grafting, the use of lumbar intrathecal catheter, and patients presenting for the resection of a craniopharyngiomas all had a significantly increased incidence of postoperative emesis (11.4%, 17.1%, and 18%, respectively). Interestingly, antiemetic prophylaxis did not decrease the risk of vomiting overall or in any cohort of patients; however, both droperidol and ondansetron decreased the incidence of nausea in the postanesthesia care unit (PACU). Regarding pain and morphine consumption, patients who later developed diabetes insipidus had a significant increase in morphine requirements in the PACU. No other disease state was associated with increased pain or morphine consumption in the PACU.

Adipose Tissue↗
PubMed2004

Low-dose granisetron for postoperative nausea and vomiting prophylaxis.

OBJECTIVE: To evaluate the use of low-dose granisetron in postoperative nausea and vomiting prophylaxis. DATA SOURCES: Clinical trials available through PubMed and OVID (1966-July 2003), as well as information supplied by the drug manufacturer, were accessed. DATA SYNTHESIS: Safety concerns associated with droperidol and limited availability of other agents have created a need to restructure prophylaxis guidelines for postoperative nausea and vomiting. It has recently been proposed that granisetron may be effective at a dose that is one-tenth of the Food and Drug Administration-approved dose. Conflicting evidence for this regimen is evaluated. CONCLUSIONS: Based on the scarcity of supporting data, this regimen is not recommended for prophylaxis in patients at risk for postoperative nausea and vomiting.

Antiemetics↗
PubMed2004

Aprepitant: a novel antiemetic for chemotherapy-induced nausea and vomiting.

OBJECTIVE: To evaluate the safety and efficacy of aprepitant in the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV). DATA SOURCES: MEDLINE and PubMed database searches were conducted from 1966 to May 2004 using the following search terms: aprepitant, Emend, substance P, neurokinin-1, chemotherapy, nausea, vomiting, L-754,030, and MK-869. STUDY SELECTION AND DATA EXTRACTION: Large, randomized Phase II and III clinical trials examining the use of aprepitant for CINV, as well as all published drug interaction studies with aprepitant, were included and reviewed. Data lacking in published trials were supplemented with the manufacturer product information. DATA SYNTHESIS: The pharmacokinetics of aprepitant are favorable for once-daily oral dosing. Based on the results of published clinical trials, aprepitant appears to augment the effects of corticosteroids and 5-HT3 antagonists when given prior to highly emetogenic chemotherapy, including cisplatin. Aprepitant appears to have the most benefit in the prevention of delayed CINV and in preventing emesis rather than nausea. Data in pediatric patients, patients undergoing stem-cell transplantation, and those receiving multiple-day or moderately emetogenic chemotherapy are lacking. Common adverse effects are limited to hiccups, asthenia, and diarrhea. More serious but rare adverse effects include neutropenia. Because aprepitant is a CYP3A4 substrate, a 3A4 inhibitor and inducer, and a 2C9 inducer, close monitoring for drug interactions is warranted. CONCLUSIONS: Triple antiemetic therapy with aprepitant, a corticosteroid, and a 5-HT3 antagonist appears to provide improved efficacy in the prevention of emesis in patients receiving highly emetogenic chemotherapy. Due to its novel mechanism of action and demonstrated efficacy in this combination, aprepitant should be considered for formulary addition.

Antiemetics↗
PubMed2002

Ramosetron, a 5-HT3 receptor antagonist for the control of nausea and vomiting.

Ramosetron is a selective serotonin 5-HT3 receptor antagonist with an affinity higher than that of the previously available drugs ondansetron, granisetron and tropisetron. Ramosetron was shown in pharmacological assays to inhibit activities mediated by 5-HT3 receptors, such as emesis caused by cisplatin. In clinical trials, ramostreon was at least as effective as the reference "setrons" against nausea and vomiting induced by chemotherapy or surgical interventions, but the efficacy was well maintained during a 48-h period, so that efficacy was significantly higher with ramosetron in terms of nausea and vomiting 6-48 h after treatment. Hence, ramosetron represents a good alternative over previously available drugs for the prophylaxis and treatment of chemotherapy-induced and postoperative nausea and vomiting. Data in children also support the efficacy of ramosetron, which is well tolerated by both child and adult patients.

Animals↗
PubMed2003

Granisetron: new insights into its use for the treatment of chemotherapy-induced nausea and vomiting.

Granisetron (Kytril, Roche) is a 5-hydroxytryptamine 3 (5-HT(3))-receptor antagonist indicated for the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic chemotherapy, including high-dose cisplatin. Its indication expanded in August 2002, with approval from the FDA for the prevention and treatment of postoperative nausea and vomiting. Granisetron strongly and selectively binds to the 5-HT(3) receptor with a binding constant of 0.26 nM and exhibits a 4000 - 40,000 times greater binding affinity for the 5-HT(3) receptor than other binding sites, including other 5HT subtypes and adrenergic, histaminergic and opioid receptors. Its selectivity to the 5-HT(3) receptor over other receptor types is > 1000:1. Granisetron noncompetitively binds to the 5-HT(3) receptor and is associated with a long duration of action as shown by the inhibition of a 5-HT axonal response flare for up to 24 h. Granisetron is unique among the 5-HT(3)-receptor antagonists because it is not metabolised via the cytochrome P450 (CYP) 2D6 pathway and is, therefore, less susceptible to variation in patient response because of factors such as pharmacogenomic differences. Granisetron and other 5-HT(3)-receptor antagonists are first-line agents for acute chemotherapy-induced nausea and vomiting (CINV), whereas combination therapy with 5-HT(3)-receptor antagonists, dexamethasone and neurokinin (NK)-1 receptor antagonism (i.e., with the recently approved aprepitant) is an effective approach to prevent delayed CINV. Granisetron has been shown to be an effective within-class rescue antiemetic for prophylactic failures, which may be linked to its pharmacological properties including non-competitive, insurmountable binding to the 5-HT(3) receptor. As with other 5-HT(3)-receptor antagonists, granisetron is well-tolerated with adverse events of mild severity including headache, asthenia and constipation. Overall, data demonstrate that granisetron is an efficacious, safe and cost-effective member of the 5HT(3)-receptor antagonist class for the prevention of CINV.

Antiemetics↗
PubMed2004

Aprepitant: a neurokinin-1 receptor antagonist for the treatment of chemotherapy-induced nausea and vomiting.

Chemotherapy-induced nausea and vomiting (CINV) is associated with a significant deterioration in quality of life, and although the use of 5-hydroxytryptamine-3 (5-HT3) receptor antagonists plus dexamethasone has significantly improved the control of acute CINV, delayed nausea and vomiting remain a significant clinical problem. Aprepitant (Emend), Merck) is the first agent available in the new drug class of neurokinin-1 receptor antagonists. When added to a standard regimen of a 5-HT3 receptor antagonist and dexamethasone in patients receiving highly emetogenic chemotherapy, it improves the complete response rate of acute CINV. Aprepitant also improves the complete response of delayed CINV when used in combination with dexamethasone compared with dexamethasone alone. Based on these studies, new guidelines for the prevention of CINV have been developed for patients receiving highly emetogenic chemotherapy. The use of aprepitant in patients receiving moderately emetogenic chemotherapy will await the review and analysis of recently completed Phase III trials. Aprepitant is a substrate, a moderate inhibitor and an inducer of cytochrome P450 (CYP)3A4 and CYP2C9. Drug interactions should be monitored when aprepitant is coadministered with agents affected by CYP3A4 and CYP2C9 isoenzymes. The safety and efficacy of aprepitant has not been established in pediatric or adolescent patients, and aprepitant has not been evaluated in the treatment of patients with established nausea and vomiting. Future studies may consider the use of aprepitant with current and other new agents in moderately and highly emetogenic chemotherapy, as well in the clinical settings of multiple-day chemotherapy and bone marrow transplantation.

Adolescent↗
PubMed2000

Pharmaceutical care of postoperative nausea and vomiting: balanced scorecard for outcomes.

Using the balanced scorecard to measure outcomes, a multidisciplinary team worked to improve antiemetic therapy and decrease postoperative nausea and vomiting. Patient satisfaction measures were nausea and pain scales (10 cm, nonnumbered, visual analog). The quality measure was number of vomiting episodes. Cost measures were length of postoperative stay and antiemetic requirement. Institutional learning was assessed by spread of prescribing changes beyond the first cohort of patients. Intervention subjects were providers of general anesthesia in two cohorts of patients (60 and 346) undergoing laparoscopic cholecystectomy. Outcome assessment revealed low nausea and vomiting scores throughout the study, and antiemetic use decreased 50%. There were no deteriorations in pain scores or length of stay. Balanced scorecard measurements suggest no adverse unintended outcomes consequent to changes in prescribing behavior. Balanced scorecard processes assisted consensus among pharmacists, nurses, and physicians that may have accelerated behavioral changes.

Adult↗
PubMed1998

Treatment of nausea and vomiting in pregnancy. When should it be treated and what can be safely taken?

Nausea and vomiting are both common in early pregnancy. Most cases are mild and do not require treatment. However, persistent vomiting and severe nausea can progress to hyperemesis if the woman is unable to maintain adequate hydration, and fluid and electrolyte as well as nutritional status are jeopardised. Hyperemesis gravidarum is a diagnosis of exclusion, characterised by prolonged and severe nausea and vomiting, dehydration, ketosis and bodyweight loss. Investigation may show hyponatraemia, hypokalaemia, a low serum urea level, metabolic hypochloraemic alkalosis and ketonuria. The haematocrit is raised and the specific gravity of the urine is increased. There may be associated liver function test abnormalities and abnormal thyroid function tests, with biochemical thyrotoxicosis with raised free thyroxine levels and/or suppressed thyroid-stimulating hormone levels. The pathophysiology of hyperemesis is poorly understood. Various hormonal, mechanical and psychological factors have been implicated. Studies have demonstrated a direct relationship between the severity of hyperemesis, the degree of biochemical hyperthyroidism and the levels of human chorionic gonadotrophin (hCG). Management of hyperemesis should include hospitalisation, intravenous fluid and electrolyte replacement, thiamine (vitamin B1) supplementation, use of conventional antiemetics and psychological support. Most patients improve spontaneously with the help of the above measures without long term sequelae. Conventionally, antiemetics are not usually prescribed, especially before 12 weeks gestation, except for women with hyperemesis. This reluctance relates to fears which are often unfounded concerning the teratogenic effects of antiemetics. Severe hyperemesis, refractory to conventional management with intravenous fluids and antiemetics is a rare, miserable and disabling condition, associated with multiple hospital admissions, time away from work and the family, and psychological morbidity. If inadequately or inappropriately treated, it may cause Wernicke's encephalopathy, central pontine myelinolysis and death. In extreme cases, women may request, or their obstetricians recommend, termination of the pregnancy. There are uncontrolled data supporting a beneficial effect of corticosteroids in these women, and a randomised placebo-controlled trial is currently in progress.

Antiemetics↗
PubMed1983

Nausea and vomiting as major complications of cancer chemotherapy.

Significant advances in the treatment of certain disseminated malignancies have been accompanied by an increased awareness of the consequences of inadequate antiemetic therapy. Nausea and vomiting are predisposing factors to patient non-compliance with treatment regimens and impose mental and physical suffering that diminishes the quality of life. The extent of medical complications associated with vomiting depends on its severity and duration and can include oesophageal tears, bone fractures, malnutrition and major metabolic derangements. The pharmacological management of chemotherapy-induced nausea and vomiting is influenced by the aetiology and mechanism as well as whether therapy is to take place in the hospital or outpatient setting. No single drug is successful in all cases. Side effects due to antiemetic drugs also limit their usefulness. Major treatment alternatives at present include the phenothiazines, antihistamines, benzquinamide derivatives, butyrophenones such as haloperidol, the dopamine receptor antagonist domperidone, and metoclopramide. Cannabinoids, particularly delta-9-tetrahydrocannabinol and nabilone have stimulated considerable research interest. Studies of the role of high dose corticosteroids either alone or in combination with other antiemetics have also been undertaken. Newer chemotherapeutic regimens are more emetic than in the past. Inadequate management of nausea and vomiting is deleterious to the health and well-being of patients and any delay in providing an aggressive therapeutic approach aggravates the problem. This symposium is designed to provide some answers to this therapeutic problem.

Antiemetics↗
PubMed1997

Dolasetron. A review of its pharmacology and therapeutic potential in the management of nausea and vomiting induced by chemotherapy, radiotherapy or surgery.

Dolasetron (dolasetron mesilate) is a pseudopelletierine-derived 5-HT3 antagonist which has recently become available for clinical use. It is rapidly converted in vivo to its active major metabolite, hydrodolasetron, which appears to be largely responsible for its pharmacological activity. In clinical trials, single intravenous or oral doses of dolasetron were effective in preventing acute chemotherapy-induced nausea and vomiting (CINV). Intravenous doses of 1.8 mg/kg achieved complete suppression of vomiting in approximately 50% of patients receiving highly emetogenic cisplatin-containing chemotherapy and in approximately 60 to 80% of patients receiving moderately emetogenic chemotherapy. In the latter setting, oral doses of 200 mg achieved similar response rates. In comparative studies, intravenous dolasetron 1.8 mg/kg was as effective as intravenous granisetron 3 mg or ondansetron 32 mg after highly emetogenic chemotherapy, and oral dolasetron 200 mg was equivalent to multiple oral doses of ondansetron (3 or 4 doses of 8 mg) after moderately emetogenic chemotherapy. Dolasetron 1.8 mg/kg was superior to metoclopramide in preventing emesis induced by high dose cisplatin or by moderately emetogenic chemotherapy in high risk subgroups. Dolasetron has also shown efficacy in preventing radiotherapy-induced nausea and vomiting (RINV) in preliminary studies. Single intravenous or oral dolasetron doses ranging from 12.5 to 100 mg and 25 to 200 mg, respectively, were significantly more effective than placebo in preventing postoperative nausea and vomiting (PONV) in female surgical patients. A 50 mg intravenous dose was as effective in preventing PONV as ondansetron 4 mg in a mixed-gender group. Intravenously administered dolasetron was also effective in treating established PONV, although complete suppression of vomiting was achieved in < 40% of patients. Dolasetron has a tolerability profile characteristic of this class of compounds, with headache, dizziness and diarrhoea being the most commonly occurring adverse events in clinical trials. Diarrhoea is not thought to be related to dolasetron administration, being experienced mostly by patients receiving chemotherapy. Dolasetron and other 5-HT3 receptor antagonists have been associated with minor changes in ECG intervals, but these generally do not appear to be clinically important. Thus, available evidence suggests that dolasetron will provide an alternative to other 5-HT3 receptor antagonists for the management of CINV and PONV. Further studies are required to determine whether it offers any advantages over other agents in these settings and to determine the optimum dosage for preventing RINV.

Administration, Oral↗
PubMed2000

Prevention and treatment of postoperative nausea and vomiting.

Pain, nausea and vomiting are frequently listed by patients as their most important perioperative concerns. With the change in emphasis from an inpatient to outpatient hospital and office-based medical/surgical environment, there has been increased interest in the 'big little problem' of postoperative nausea and vomiting (PONV). Currently, the overall incidence of PONV is estimated to be 25 to 30%, with severe, intractable PONV estimated to occur in approximately 0.18% of all patients undergoing surgery. PONV can lead to delayed postanaesthesia care unit (PACU) recovery room discharge and unanticipated hospital admission, thereby increasing medical costs. The aetiology and consequences of PONV are complex and multifactorial, with patient-, medical- and surgery-related factors. A thorough understanding of these factors, as well as the neuropharmacology of multiple emetic receptors [dopaminergic, muscarinic, cholinergic, opioid, histamine, serotonin (5-hydroxy-tryptamine; 5-HT)] and physiology [cranial nerves VIII (acoustic-vestibular), IX (glossopharyngeal) and X (vagus), gastrointestinal reflex] relating to PONV are necessary to most effectively manage PONV. Commonly used older, traditional antiemetics for PONV include the anticholinergics (scopolamine), phenothiazines (promethazine), antihistamines (diphenhydramine), butyrophenones (droperidol) and benzamides (metoclopramide). These antiemetics have adverse effects such as dry mouth, sedation, hypotension, extrapyramidal symptoms, dystonic effects and restlessness. The newest class of antiemetics used for the prevention and treatment of PONV are the serotonin receptor antagonists (ondansetron, granisetron, tropisetron, dolasetron). These antiemetics do not have the adverse effects of the older, traditional antiemetics. Headache and dizziness are the main adverse effects of the serotonin receptor antagonists in the dosages used for PONV. The serotonin receptor antagonists have improved antiemetic effectiveness but are not as completely efficacious for PONV as they are for chemotherapy-induced nausea and vomiting. Older, traditional antiemetics (such as droperidol) compare favourably with the serotonin receptor antagonists regarding efficacy for PONV prevention. Combination antiemetic therapy improves efficacy for PONV prevention and treatment. In the difficult-to-treat PONV patient (as in the chemotherapy patient), suppression of numerous emetogenic peripheral stimuli and central neuroemetic receptors may be necessary. This multimodal PONV management approach includes use of: (i) multiple different antiemetic medications (double or triple combination antiemetic therapy acting at different neuroreceptor sites); (ii) less emetogenic anaesthesia techniques; (iii) adequate intravenous hydration; and (iv) adequate pain control.

Anesthesia↗
PubMed2006

Efficacy of granisetron for the treatment of postoperative nausea and vomiting in women undergoing breast surgery: a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Women undergoing general anaesthesia for breast surgery are especially at risk of experiencing postoperative nausea and vomiting (PONV). This study was undertaken to assess the efficacy of granisetron, a selective serotonin type 3 receptor antagonist, for the treatment of postoperative nausea and vomiting after breast surgery. DESIGN AND METHODS: This was a prospective, randomised, double-blind, placebo-controlled study carried out in a university-affiliated teaching hospital. The study included women who experienced nausea lasting >10 minutes and/or vomiting during the first 3 hours after recovery from anaesthesia for breast surgery. Patients intravenously received either placebo or granisetron at four different doses (10 microg/kg, 20 microg/kg, 40 microg/kg and 80 microg/kg). Patients were observed for 24 hours after administration of the study drug. MAIN OUTCOME MEASURES AND RESULTS: A total of 100 women were enrolled in this study. Complete control of established PONV, defined as no emetic symptoms and no need for a rescue antiemetic, was observed in 50% of women receiving granisetron 10 microg/kg (p = 0.5 vs placebo), 85% of women receiving granisetron 20 microg/kg (p = 0.009 vs placebo), 90% of women receiving granisetron 40 microg/kg (p = 0.003 vs placebo), and 85% of women receiving granisetron 80 microg/kg (p = 0.009 vs placebo), compared with 45% of placebo recipients. The efficacies of granisetron 20 microg/kg, granisetron 40 microg/kg, and granisetron 80 microg/kg for the treatment of established PONV were superior to that of granisetron 10 microg/kg (all p < 0.05). No serious adverse effects were observed in any group. CONCLUSION: The minimum effective dose of granisetron for the treatment of PONV in women undergoing breast surgery was 20 microg/kg. Increasing the granisetron dose to 80 microg/kg provided no further benefit.

Antiemetics↗
PubMed2003

Options for the prevention and management of acute chemotherapy-induced nausea and vomiting in children.

The current standard of care with respect to preventing acute chemotherapy-induced nausea and vomiting (CINV) in children includes the administration of a 5-HT(3) antagonist with or without a corticosteroid, depending on the emetogenicity of the chemotherapy to be given. Problems in assessing the emetogenicity of chemotherapy regimens and nausea severity in children may influence the degree of success of CINV prophylaxis. Nevertheless, the majority of children who receive chemotherapy today experience moderate to complete control of acute CINV when given appropriate antiemetic prophylaxis. If children vomit or experience nausea despite appropriate prophylaxis, then measures must be taken to treat these symptoms since these children are likely to go on to experience delayed or anticipatory CINV. However, appropriate selection of interventions to treat acute CINV in children is limited by the lack of rigorous evidence to support one approach over another. Lorazepam is suggested as an immediate agent for the treatment of acute CINV. Doses and frequencies of the 5-HT(3) antagonist and corticosteroid administered for initial prophylaxis should also be maximized. Further treatment must be tailored to the circumstances and preferences of each child and family. Options include crossover to another 5-HT(3) antagonist, or administration of an adjunctive antiemetic such as metopimazine, low dose metoclopramide, domperidone, alizapride, nabilone, scopolamine, prochlorperazine, or chlorpromazine. Complementary interventions such as acupuncture, hypnosis, counseling, or ginger may also be of benefit. Further study is required to establish optimal antiemetic strategies in children.

Acute Disease↗
PubMed1997

Oral ondansetron 8 mg twice daily is as effective as 8 mg three times daily in the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. S3A-376 Study Group.

The efficacy and safety of ondansetron 8 mg BID compared with 8 mg TID for 3 days in the prevention of nausea and vomiting in 402 patients on cyclophosphamide (> or = 500 mg/m2)-based chemotherapy were evaluated in a multicenter, randomized, double-blind, stratified study. The percentage of patients with no emetic episodes over the 3-day study period was 61% in the ondansetron BID group compared with 58% in the ondansetron TID group. Among patients with at least one emetic episode, the mean time to emesis was 14 hr and 17 min in the ondansetron BID group compared with 12 hr and 48 min in the ondansetron TID group. Patients' daily appetite ratings and nausea scores were not significantly different between groups. Clinical laboratory and adverse event profiles were similar between groups. This study is the first large-scale, double-blind trial to demonstrate that ondansetron 8 mg BID for 3 days, a dosing regimen that may enhance patient convenience and compliance, is as effective as ondansetron 8 mg TID for 3 days in the prevention of nausea and vomiting associated with cyclophosphamide-based chemotherapy.

Administration, Oral↗
PubMed1993

Nausea, abdominal pain and diarrhoea of uncertain cause responding to ondansetron.

OBJECTIVE: To assess the value of ondansetron in a patient with intractable nausea, abdominal pain and diarrhoea unrelated to cancer chemotherapy or radiotherapy. CLINICAL FEATURES: A 33-year-old teacher presented with a three-and-a-half-year history of nausea, abdominal pain and diarrhoea. She attended a consulting room in private practice for a second opinion as her symptoms had not responded to routine management of "irritable bowel syndrome". INTERVENTION: A prospective, non-placebo-controlled study was undertaken whereby she received ondansetron 8 mg three times daily for five days. Before ingestion of ondansetron it was planned that the efficacy of this new drug would be assessed by the clinical response and measured by the values obtained in a three-day faecal fat collection. OUTCOME: There was clinical benefit during the period of ingestion of ondansetron. In this time faecal weight and faecal fat excretion were reduced when compared with the results of similar collections (baseline study, and following the ingestion of pancreatic supplements) performed before the administration of ondansetron. CONCLUSION: The benefit obtained warrants further assessment. If confirmed, the results may suggest a role for ondansetron in the management of nausea and vomiting unrelated to cancer chemotherapy and radiotherapy.

Abdominal Pain↗
PubMed1981

Gastric and small intestinal myoelectric dysrhythmia associated with chronic intractable nausea and vomiting.

We describe a patient with symptoms of severe nausea, vomiting, epigastric bloating and pain, and marked weight loss due to a gastrointestinal motility disturbance. Motility abnormalities were characterized by uncoordinated high pressure (as high as 300 mm Hg) contractions and uncoordinated interdigestive motor complexes in the duodenum and small intestine, and tachygastria often associated with tachyarrhythmia in the gastric myoelectric activity recordings. Uncoordinated interdigestive myoelectric complexes again were found in the duodenum and small intestine. These abnormal myoelectric activities observed in the in-vivo study were confirmed in the in-vitro study. After distal hemigastrectomy and gastrojejunostomy, the symptoms of nausea, vomiting, and epigastric pain decreased considerably. Thus, the motility abnormality found in the study appears to be responsible for the symptoms described. This is probably a new clinical entity. The importance of manometric and myoelectric study of a gastrointestinal motility for unexplained nausea and vomiting is emphasized.

Adult↗
PubMed1998

Oral granisetron as prophylaxis for nausea and vomiting during fluorescein angiography. A multicentre, double-blind, randomised, parallel group, placebo-controlled study.

BACKGROUND: Prophylaxis with oral Granisetron was assessed in patients undergoing fluorescein angiography (FAG) in order to evaluate its efficacy in reducing patients' discomfort due to nausea and vomiting (4% > 20%) and to ensure completion of the investigation. EXPERIMENTAL PLAN: Multicentre, randomised, double-blind, placebo-controlled study, with a follow-up visit performed 24 hrs after FAG. ENVIRONMENT: Five Anaesthesia/Resuscitation and Ophthalmology operational units participated in the study. PATIENTS: 120 patients (24 from each Centre) of both sexes and aged > 18 years, suffering from retinal disorders, were enrolled after informed consent. Pregnancy, lactation, anti-neoplastic treatment, ASA status IV/V were main exclusion criteria. All recruired patients completed the study. INTERVENTIONS: Ophthalmological evaluation was performed 30 days before and the same day as FAG. Anaesthesiological assessment on the same day as FAG, recording, BP, HR, ASA status, allergic diathesis, allergy to medications and contrast media, concomitant treatments. Oral Granisetrom 1 mg or placebo was given on an empty stomach 1 hr before the injection of 5 ml 20% fluorescein in 3 sec. A follow-up examination was done 24 hrs after FAG. SURVEY: In both groups nausea, retching and vomiting were seen after fluorescein injection. RESULTS: The study demonstrated that Granisetron is more active than placebo in controlling nausea (3 cases vs 4), and retching (2 vs 6). It was significantly more effective than placebo in the prevention of vomiting (0 vs 3). Efficacy was evaluated with chi 2, p < or = 0.05). CONCLUSIONS: The results suggest that Granisetron may be indicated as prophylaxis in patients undergoing FAG in order to prevent or control emesis, improve patients' comfort and ensure successful outcome of the investigation.

Administration, Oral↗
PubMed1999

[Effects of intravenous and oral administration of ondansetron hydrochloride on chemotherapy-induced nausea and vomiting in patients with esophageal cancer].

The effects of ondansetron hydrochloride (OND) were studied through 11 courses of chemotherapy, including 70 mg/m2 of cisplatin, in 9 patients with advanced esophageal cancer. During the observation period of 5 days, 4 mg of OND was given intravenously on the day of cisplatin infusion and orally for consecutive 4 days, and nausea was controlled by over 70%. Vomiting was controlled by over 80%. The inhibitory effect of OND on nausea and vomiting was found in 72.7% on the day of cisplatin injection and 88.9% overall. No other side effects of OND except slight increases in total bilirubin and LDH were found in any patient. These findings suggest that intravenous and oral administration of OND may inhibit chemotherapy-induced nausea and vomiting in patients with advanced esophageal cancer.

Administration, Oral↗