Abstract Background Ramosetron is a new selective 5-hydroxytryptamine type 3 5-HT3 receptor antagonist that reportedly has more potent antiemetic effects compared with other 5-HT3 receptor antagonists. The purpose of this study was to evaluate the efficacy of ramosetron for the prevention of postoperative nausea and vomiting PONV with that of ondansetron or placebo in high-risk patients undergoing gynaecological surgery. Methods In this prospective, randomized, double-blinded, placebo-controlled study, healthy patients who were undergoing gynaecological operation under general anaesthesia using sevoflurane were enrolled. Patients were divided into three groups:
Previous Section Next Section Introduction Highly emetogenic chemotherapeutic agents, including cisplatin, are widely used in treating malignant disease. Nausea and vomiting are the most frequently occurring side effects of therapy with these agents.
Physiologically, serotonin and 5-HT3 receptors play key roles in the induction of nausea and vomiting by chemotherapeutic agents [ 4 - 7 ]. Ondansetron is a selective 5-HT3 receptor antagonist highly effective in controlling nausea and vomiting in a variety of clinical situations.
Additionally, numerous studies investigating the use of ondansetron and granisetron, another 5-HT3 receptor antagonist, have shown that when delivered intravenously both drugs are safe and highly effective in preventing nausea and vomiting induced by moderately high or highly emetogenic chemotherapy [ 48 - 15 ].
Studies have also been conducted which demonstrate similar efficacy results with oral granisetron 2 mg and i.
Although oral ondansetron at doses of 8 mg TID and 8 mg BID has been proven effective for use in moderately emetogenic chemotherapy, the optimal oral ondansetron dose and regimen for patients receiving highly emetogenic chemotherapy has not been clearly defined.
A single oral dose of ondansetron 24 mg was chosen for investigation in this study. It was theorized that having the most ondansetron available to interact with the 5-HT3 receptors at the time of maximal release of serotonin, 2 to 6 h following cisplatin administration [ 8 ], would provide the greatest antiemetic efficacy.
Using this same logic, the approved oral dosing regimen of ondansetron 8 mg TID effective in moderately emetogenic chemotherapy regimens was combined into a single oral dose 24 mg to be administered prior to a cisplatin-based chemotherapy regimen.
Although numerous reports in the literature state that the use of dexamethasone adds to the efficacy of the 5-HT3 receptor antagonists, corticosteroids including dexamethasone were excluded from the study in order to demonstrate the antiemetic activity of a single oral dose of ondansetron and a single i.
Patients and Methods Patient Selection Two identically designed multicenter, randomized, double-blind, parallel-group studies were conducted. Females were eligible if surgically sterilized, post-menopausal, or pre-menopausal with a negative pregnancy test.
Medications with antiemetic properties were not allowed within 24 h prior to or during the study period. Patients could not undergo radiation therapy to the abdomen or pelvis within 48 h prior to or during the study period.
The protocol was reviewed and approved by the Institutional Review Board at each study site and written informed consent obtained from each patient prior to the performance of any study-related procedures.
Antiemetic Treatment Patients were randomized 1: The co-administration of corticosteroids, including dexamethasone, was not permitted.
The administration of rescue antiemetic therapy was allowed at the discretion of the investigator if emetic symptoms were not controlled by the study drug. Assessment of Antiemetic Efficacy and Safety Efficacy data were collected for each patient for 24 h after the start of cisplatin administration.
The primary efficacy variable was the number of patients with no emetic episodes who completed the trial without rescue medication complete response [CR]. Secondary efficacy parameters included the number of patients with therapeutic failures i.
Subjective measures of efficacy included patient assessment of nausea, appetite, and satisfaction with antiemetic therapy. Patient assessment of nausea was performed using an point linear numerical scale ranging from 0 no nausea to 10 nausea as bad as it could be.
Patient satisfaction with antiemetic therapy was rated using a 5-point scale ranging from 1 very satisfied to 5 very dissatisfied. Safety evaluations were based on reports of adverse events defined as any untoward medical occurrence and laboratory data.
Adverse events were monitored from the time of study drug administration up to Adverse events considered by investigators to be potentially related to study drug were documented for up to eight days after study drug administration.
Laboratory studies monitoring hematological parameters and blood chemistries including liver function tests were performed within seven days of the start of study drug administration and within eight days following the end of study drug administration.
Any laboratory test results out of the normal range which were judged to be potentially drug related or clinically relevant were repeated and followed until return to normal or explained to the satisfaction of the investigator.
Statistical Methods As the two studies were identical, data were combined and analyzed as a single trial. The safety population consisted of all patients who received at least one dose of study medication. The intent-to-treat population comprised all patients in the safety population who received cisplatin or carboplatin chemotherapy and was used for all study endpoints.
The primary efficacy analysis compared the number of patients in each treatment group who experienced a CR during the post-treatment period.
Patients who reported more than five emetic episodes, who were rescued with additional medications, or who were withdrawn due to lack of efficacy were assigned the same arbitrarily high value for the number of emetic episodes i. The number of patients in each group with a complete or major response was also compared.
Time to treatment failure first emetic episode, rescue, or withdrawal was assessed using Kaplan-Meier methods, and treatment groups were compared using log-rank tests. Nausea and appetite assessments were analyzed with overall scores compared between treatment groups using Mantel-Haenszel methods." tone of essay writing, thesis on weed science weed control, thesis on comparison between granisetron and ondansetron pon, write good gcse history essay Oklahoma State University.
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write good gcse history essay Colorado State University! web. A Comparison of Oral Ondansetron and Intravenous Granisetron for the Prevention of Nausea and Emesis Associated with Cisplatin-Based Chemotherapy.
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.
Aims and Objectives: To compare the effectiveness of Ondansetron with dexamethasone to that of Granisetron with dexamethasone for prevention of post operative nausea and vomiting (PONV) after. Apr 27, · To compare the efficacy of intravenous ondansetron (4 mg, 2 mL) and granisetron (2 mg, 2 mL) for preventing postoperative nausea and vomiting (PONV) in patients during oral and maxillofacial surgical procedures under general anesthesia.
Full-Text Paper (PDF): Granisetron vs ondansetron for prevention of nausea and vomiting in hematopoietic stem cell transplant patients: .