View clinical trials related to Vomiting.
Filter by:The purpose of this study is to evaluate the effectiveness of low dose dexamethasone versus high dose dexamethasone in the treatment of radiation induced vomiting.
"The purpose of this investigator-initiated study is to see if giving dextrose fluid in the veins (IV) decreases the risk of postoperative nausea and vomiting (PONV) in female urologic, gynecologic and breast outpatient surgery patients and at what blood surgery level. The reason for this study is that IV dextrose has been shown to decrease the incidence of PONV and the use of medications to treat PONV, while leading to sooner discharge after surgery. This can decrease overall healthcare cost and improving patient satisfaction."
Postoperative pain, nausea and vomiting (PONV) are the most common complications after anesthesia and surgery. Women undergoing mastectomy with axillary dissection are at a particularly high risk for the development of PONV and an incidence of 60-80% in patients receiving no antiemetic has been reported. Emetic episodes predispose to aspiration of gastric contents, wound dehiscence, psychological distress, and delayed recovery and discharge times. These justify the use of prophylactic antiemetics in women scheduled for mastectomy. Most of the currently used antiemetics, including antihistamines, butyrophenones and dopamine receptor antagonists have been reported to cause occasional undesirable adverse effects, such as excessive sedation, hypotension, dry mouth, dysphoria, hallucinations and extrapyramidal signs. Antiserotonins (e.g., ondansetron) are available for the prevention and treatment of PONV in patients undergoing various types of surgery [4]. However, the use of prophylactic antiemetic therapy with antiserotonins has been criticized for being too expensive. Dexamethasone was first reported to be an effective antiemetic regimen in patients receiving cancer chemotherapy. The purpose of this study was to evaluate the efficacy of dexamethasone treatment for reducing pain and PONV as well as analgesic and antiemetic requirements in women undergoing general anesthesia for mastectomy with axillary lymph node dissection.
The purpose of this prospective, randomized, double-blinded, active-controlled study is: To assess the effectiveness of systemic administration of lidocaine and esmolol in combination (vs. either drug alone) will result in improved postoperative outcomes for patients undergoing abdominal surgery (e.g., less pain and postoperative constipation, nausea and vomiting, faster return of bowel function, resumption of normal activities of daily living), leading to a shorten length of hospital stay, maintaining hemodynamic stability during general anesthesia, when administered as intravenous adjuvants
Delayed nausea is a common problem after high dose chemotherapy for bone marrow transplantation. This study wants to compare standard prophylactic anti-emetic therapy with the same treatment plus the drug aprepitant (Emend). The hypothesis is that addition of Emend will reduce nausea and vomiting.
Risk factors for postoperative shoulder pain after laparoscopic cholecystectomy were not clear. Moreover, risk factors for postoperative emesis specially for this surgery were not detailed and accurate. The present study is a prospective cohort study to identify risk factors for shoulder pain and emesis within 24 hours in Chinese patients after laparoscopic cholecystectomy under general anesthesia.
Null hypothesis The proportions of vomiting are not different between dexamethasone and placebo in the patient after sedation with intravenous ketamine and lumbar puncture with intrathecal chemotherapy Alternative hypothesis The proportions of vomiting are different between dexamethasone and placebo in the patient after sedation with intravenous ketamine and lumbar puncture with intrathecal chemotherapy
Title of the study Aprepitant for prevention of acute and delayed nausea and vomiting: a phase III, double-blind, randomized, placebo-controlled trial in patients receiving a high-emetogenic dose of cyclophosphamide for peripheral blood stem cells harvesting Objective(s) Primary objective: to confirm and extend the investigators preliminary data on the efficacy and safety of combined aprepitant, palonosetron and dexamethasone in preventing CINV after high emetic therapy with cyclophosphamide 3 g/m2 compared with the palonosetron and dexamethasone regimen. Secondary objective: to monitor peripheral blood stem cell harvest. Methodology Single centre, randomized, double-blind, placebo-controlled phase III trial Endpoints Primary endpoint: the complete response (CR) rate defined as the number of patients with no emetic episodes and no rescue medication in the first 120 hours post-chemotherapy. Secondary endpoints: - CR rates for acute (0-24 h) and delayed (24-120 h) phases; - complete control rate (CC) defined as no emetic episode, no rescue medication use and no more than mild nausea; - number of emetic episodes; - severity of nausea; - impact of CINV on daily life as measured by the Functional Living Index-Emesis (FLIE) (total score > 108 = no impact); - peripheral blood stem cell harvest; - tolerability (adverse events, drug-related adverse events, serious adverse events; discontinuation of treatment due to an adverse event). Adverse events will be classified using NCI Common Toxicity Criteria. Number of patients A total of 120 patients will be enrolled Inclusion criteria - Male or female patients ≥ 18 years of age - Patient is able to understand study procedure and agrees to participate in the study by giving written informed consent. - Patient is scheduled to receive a highly emetogenic cyclophosphamide IV chemotherapy (3 g/m2) for autologous PBSC harvesting - Karnofsky score ≥60 - Normal laboratory values - Normal ECG - HBV-, HCV- and HIV- negative - Negative urine pregnancy test for women of childbearing age Treatment Eligible patients will be randomized to receive oral doses of Aprepitant (125 mg day 1, 80 mg days 2 and 3), dexamethasone (8 mg/day for 3 days) and a single intravenous dose of palonosetron (0.25 mg on day 1) versus placebo plus dexamethasone (8 mg/day for 3 days) and a single intravenous dose of palonosetron (0.25 mg on day 1) Duration of study 3 years Criteria for evaluation Efficacy and safety data will be obtained using the patient's daily diary (days 1 through 5) reporting the number of episodes of retching and vomiting, severity of nausea (using a categorical scale of none, mild, moderate or severe), and overall quality of life. The FLIE 8 questionnaire will be completed on days 1 (before starting chemotherapy) and 6 (after chemotherapy). All side effects attributed to this combination therapy will be recorded daily. Safety parameters: medical history, clinical examination and weight, vital signs, laboratory tests (hematology, chemistry, urine analysis and urine pregnancy test for women of childbearing age). Statistical aspects Sample size was defined assuming the cumulative incidence rate of the primary endpoint to be 68% in the treatment group and 41% in the control group. With balanced allocation in the two groups, considering a two sided test with α=0.05 and ß=0.20 a total of 110 patients is needed. As few withdrawals and drop-outs are expected a total of 120 patients will be enrolled. Intention to treat approach will be used for all efficacy analysis. The primary endpoint will be analysed by binomial logistic models. The dependent variable will be vomiting yes/no during the first 120 hours after chemotherapy. Anti-emetic treatment, gender and age will enter as explicative variables. Dichotomous secondary endpoints will also be analysed by binomial logistic models. Multinomial logistic models will analyze the severity of nausea, stratified in 4 classes. Generalized Linear Models will investigate quantitative variables such as number of retching or vomiting episodes and peripheral blood stem cell harvest. In all tests, p value <0.05 will be considered statistically significant. No interim analyses are planned.
GAND-emesis is a multinational, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and tolerability of a neurokinin1 receptor antagonist (fosaprepitant dimeglumine) in combination with an antiemetic (anti-nausea-and-vomiting) control regimen (palonosetron and dexamethasone) in patients with a gynaecological cancer diagnosis, who are scheduled to receive radiotherapy and weekly chemotherapy. The study aims at investigating if a three-drug antiemetic regimen is superior to a two-drug regimen (standard treatment) in preventing nausea and vomiting in patients receiving radiotherapy and weekly chemotherapy. A pilot study demonstrated that approximately 50% of patients will experience nausea and vomiting when offered a two-drug antiemetic regimen, and it is expected that addition of a third drug (a neurokinin1 receptor antagonist) can increase the proportion of patients with no vomiting in the course of combined chemo-radiotherapy.
To compare ondansetron, metoclopramide, diphenhydramine, and placebo in order to determine which anti-emetic is most efficacious as a "rescue therapy" for pediatric patients ages 3-18 who have post-operative vomiting after a standardized prophylactic regimen of ondansetron and dexamethasone. We hypothesize that anti-emetics with a different mechanism of action than the prophylactic regimen will be the most effective "rescue therapy" in children having surgery in an ambulatory surgery center. 1. Problem: Despite commonly-used anti-emetics for prophylaxis, some children still go on to develop post-operative vomiting (POV). Goal: To determine which anti-emetic--ondansetron, metoclopramide, diphenhydramine, or placebo--is most efficacious for pediatric patients in this situation. 2. Hypothesis: Anti-emetic medications that have a different mechanism of action than the prophylactic regimen will be the most efficacious "rescue therapy." 3. Hypothesis: Metoclopramide at the dose of 0.5 mg/kg (max dose 20 mg) will be more effective than ondansetron, diphenhydramine, or placebo as "rescue therapy."