The Effects of Early Administration of Dolasetron on Postoperative Nausea - Case Study Example

The Effects of Early Administration of Dolasetron or Ondansetron on Postoperative Nausea and Vomiting Introduction Postoperative Nausea and Vomiting (PONV) can be considered as one of the consequences of surgical operations that is continuously being resolved to lessen the discomfort of the patients. Although the said condition can be attributed to the different types of risk factors such as physical and health condition, the main contributing cause can be related to the type of surgical procedures such as gynecological, abdominal or gastrointestinal, laparoscopic, and the procedures that are related to the eyes, ears, nose and throat. The said procedures can be associated to comparatively higher need for anesthesia increases the risk for PONV on the basis of the side effects of the said medication. Such discomfort can even be intensified on the occurrence of the different forms of pain being experienced as an effect of the operation (Lobato, Gravenstein and Kirby, 2007). Due to the fact that the PONV can be considered a common effect of surgical procedures, the continuous exploration of the most effective medications and interventions is one of the priorities of the people in the field. Objectives of the Study The main purpose of the study is to be able to compare the effects of early administration of dolasetron versus ondansetron on the prophylaxis of postoperative nausea and vomiting. The study will be undertaken through a comparative exploratory research on the reaction of the sample population which are patients that had undertaken an operation. Justification of the Study The establishment of knowledge regarding the most effective medication is the current process in relation to the observations that medications that are available to control PONV can have different side effects on their own that can bring about discomfort to the patient. There are different medications that can be applied to achieve certain degree of relief for the patients that are susceptible to PONV, and the main focus of the study is to target the determination of two of the medication for PONV. The background study will enable the establishment of concepts on the bases of the results of past studies. By pursuing the research, a study on the basis of an in-depth analysis of the results of can be achieved. There are different interventions available but the main focus in the study are the medications that exhibit antiemetic effects specifically those that belong to the group 5-HT3 antagonists namely ondansetron and dolasentron. Hypothesis The administration of ondansetron 15 to 30 minutes after the start of surgery will be more effacious than the administration of dolasetron 15 to 30 minutes after the start of surgery in decreasing postoperative nausea and vomiting. In line with the aim to test the hypothesis regarding the effects of the said medications, theories and results that had been gathered related to the types of medications, the timing of the intervention and the efficacy of the different types for PONV serve as the bases for the study. In turn, the results of the study to be undertaken can be another contribution to the establishment of the most effective intervention to cure PONV. Background of the Study The focus of the study can be related to different factors which include the early administration of the medication, the comparative effects of dolasentron and ondansetron and the projected efficacy of the said intervention. In relation to the timing of the administration of the medication, there are different results in the study undertaken. One is the study which is aimed to determine the importance in the timing of dolasetron of different dosage as well as placebo. This resulted to varying reponse in terms of the dosage as well as the timing of the intervention but mainly led to the conclusion that 12.5 mg IV dose of dolasetron if administered toward the end of anesthesia can have similar result as that of higher dose upon the start of the procedure (Korttila and Jokinen, 2004). The particular result then indicates the efficacy of the particular medication at the end of the anesthesia effect. Based on the results of similar study then, the determination of the comparative effects of two antiemetic medication had been determined for the administration toward the end of the procedure. For the particular study undertaken then, the early administration of the medication on the two antimemetic is to be tested. This can be considered similar to comaprative setups presented in different research on PONV (Zafar, Aftab and Haider, 2008). Another issue is related to the efficacy of the dolasentron and ondansetron on the basis of the study that had been already undertaken prior to the research. The said medication can be considered to belong in the class of drugs that are commonly used for the intervention of ailments such as PONV which are also referred to as histaminic or seratonergic (5-HT3 antagonists) (Islam and Jain, 2004). In the study by Zafar, Aftab and Haider, ondansetron had been applied in combination to dexamethasone which resulted in higher efficacy as compared to dexamethasone alone (2008). Similar results regarding the combination of ondansetron and dexamethasone had been achieved by Paech et al. in relation to ambulatory cases of administration of anesthesia (2007). In the study conducted by Bridges et al. wherein the different types of antiemetics had been comparatively analyzed including dolasetron, ondansetron and granisetron with the first two exhibiting equal efficacy with 12.5 mg and 4 mg respectively and granisetron exhibiting higher efficacy at 1 mg (2006). The said study presented one of the comparative efficacy results between the medications under study. In terms of the experimental procedure, on the basis of different studies that can be considered, a randomized process that are double blind, parallel and controlled clinical trial is the most effective basis of results gathered (Bridges et al., 2006; Habib et al., 2004; Korttila and Jokinen, 2004; Lobato, Gravenstein and Kirby, 2007; Paech et al., 2007). Based on the assimilation of the different results of related studies, it can be considered that a multimodal intervention specifically in the administration of the antiemetic prophylaxis has higher efficacy. Although this is the case, the study to be undertaken is specifically targeted to determine the comparative effects of two antiemetic agents thus specificity on administration is required. Research Plan Different procedures are needed to be employed to be able to achieve the projected results of the study. In relation to the objectives of the study the planning of the procedure to be undertaken can be considered as a fundamental issue. Due to the fact that the study is related to the application of the medication and observation of the different setups, the techniques in an experimental research can be considered as the most efficient. In addition, factors such as the limitations of the study, the steps making up the planning phase of the research process, and the decisions on the most effective research technique to be undertaken are among the primary concerns. 1. Design The experiment will be undertaken through a randomized double blind, parallel, controlled and multicenter clinical trial wherein placebo set-up is used with common endpoints. 2. Setting The trials will be undertaken in 4 public hospitals in the area. 3. Patients The inclusion criteria in the study are surgical procedure and the use of general anesthesia regardless of the gender thus consist of the females that had been admitted due to surgical procedures, most commonly related to gynecologic reasons and males that are admitted sue to different procedures e.g. orthopedic, ophthalmologic, urologic, ENT, or laparoscopic surgery. Exclusion criteria in the study include allergic reaction to either dolasetron or ondansetron which can be determined through the preliminaty PONV propylaxis and data gathering. 4. Number of Subjects The number of subjects that will be used in the study depends on the total inpatient admission in the hospitals under study during the set period chosen on the basis of the inclusion and exclusion criteria. The patients to be included in the study then will be divided into the three set-ups mainly dolasetron, ondansetron and the placebo for every hospital and medical facility that is included. 5. Intervention Prior to the administration of the antiemetics, general anesthesia had been given to the patients. It is important to take note that the dose that will be given is in the early part of the procedure to be able to insure the objectives of the research to be undertaken. The medication then can be classified as PONV preventive. The set-up for dolasetron is an administration of a 12.5 mg dose for the assigned group that is randomly chosen for the particular institution. For the ondansetron, 4 mg dose will be administered. Observations will be recorded on the early period (0-6 hrs) upon administration. Final assessment will be undertaken after 24 hrs. Double blinded procedure is maintained through the prevention of indicating the PONV medication used for the patients. Similarly, to be able to retain the said conditions, the medical practitioners and professionals e.g. anesthesiologists, surgeons and nurses are not aware of the specific antiemetic in the intervention. Dilution of the dolasetron is necessary to be able to reduce the identifiable differences in the dose. 6. Data Gathering The primary step required is the preparation of the needed experimental setup and processing of papers specifically related to the authorization of the process to prevent problems such as the double blinded set up. The recognition of the patients to be included in the process on the basis of the inclusion-exclusion criteria is the subsequent process along with the employment of the techniques for randomization. The data will be gathered by the researcher through close interaction with hospital personnel. 7. Organization of Data and Analysis Data that will be gathered is organized and statistically analyzed. In addition, the total response to medication can be described as the prevention of PONV toward the end of the period expected. This can be considered positive response and will be noted to require no further PONV intervention. Another indicator of positive and complete response to medication is the absence of nausea and vomiting. In terms of nausea, specific rate can be measured based on the visual analog scale (VAS). Specifically, a less than 5 mm measurement is an indication that there is no nausea. 8. Validity The validity in the study to be undertaken can be achieved though the application of techniques experimental process such as the random sampling which increases statistical validity and significantly ensures the reduction of errors incurred. In addition the said technique ensures the quality of the data gathered. Validity can also be achieved through the indication of different conditions that can be incurred in the experimental process. One of these considered is the exemption of other hospital personnel in the double blinding specifically the staffs in the pharmacy wherein the medications can be derived or other such sources of the materials that will be used in the experimental process that will be undertaken. Another condition is related to the specificity of the anesthesia that will be used. The said condition is not covered in the study to be undertaken, thus, the effects of the variation in the type and dose of anesthesia used will be assumed as constant. 9. Ethical Considerations With regards to the undertaking, the aims and the objective of the experimental research is important on the study. To be able to undertake such projects, permission is sought from the authorities and the designated groups. The ethical concerns are important specifically due to the fact that the research to be conducted is a double blinded process that involves the study of the reaction of the patients to the medication for PONV. In such cases, consent is required but since the importance of preventing errors is as important specifically due to the validity of the results, such requirements that are based on ethical considerations are waived. Reference: Bridges, J. D., Nettle, C. B., Dugirrala, V. J., Suda, K. J. and Garey, K. W. (2006) Low-dose Granisetron for the Prevention of Postoperative Nausea and Vomiting. The Journal of Applied Research, 6(3), p.223-9. Habib, A. S., White, W. D., Eubanks, S., Pappas, T. N., Gan, T. J. (2004) A Randomized Comparison of a Multimodal Management Strategy Versus Combination Antiemetics for the Prevention of Postoperative Nausea and Vomiting. Anesth Analg, 99, p. 77-81. Islam, S. and Jain, P. (2004) Post-operative Nausea and Vomiting (PONV): A Review Article. Indian J. Anaesth, 48(4), p. 253-538. Korttila, K. T., Jokinen, J. D. (2004) Timing of administration of dolasetron affects dose necessary to prevent postoperative nausea and vomiting. Journal of Clinical Anesthesia, 16 (5), p. 364-370. Lobato, E. B., Gravenstein, N. and Kirby, R. R. (2007) Complications in Anesthesiology. Lippincott Williams & Wilkins. Paech, M. J., Rucklidge, M. W. M., Lain, J., Dodd, P. H., Bennett, E. M. and Doherty, D. A. (2007) Ondansetron and Dexamethasone Dose Combinations for Prophylaxis Against Postoperative Nausea and Vomiting. Anesth Analg, 104, p. 808-814. Wallenborn, J., Gelbrich, G., Bulst, D., Behrends, K., Wallenborn, H., Rohrbach, A., Krause, U., Kühnast, T., Wiegel, M., and Olthoff, D. (2006) Prevention of postoperative nausea and vomiting by metoclopramide combined with dexamethasone: randomised double blind multicentre trial. BMJ, 333(7563), p. 324. Zafar, B. F. Aftab, S. and Haider S. (2008) Dexamethasone plus ondansetron for prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: a comparison with dexamethasone alone. J Coll Physicians Surg Pak, 18(5), p. 265-9. Read More