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      Palonosetron has superior prophylactic antiemetic efficacy compared with ondansetron or ramosetron in high-risk patients undergoing laparoscopic surgery: a prospective, randomized, double-blinded study

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          Abstract

          Background

          Postoperative nausea and vomiting (PONV) continues to be a major problem, because PONV is associated with delayed recovery and prolonged hospital stay. Although the PONV guidelines recommended the use of 5-hydroxy-tryptamine (5-HT 3) receptor antagonists as the first-line prophylactic agents in patients categorized as high-risk, there are few studies comparing the efficacies of ondansetron, ramosetron, and palonosetron. The aim of present study was to compare the prophylactic antiemetic efficacies of three 5HT 3 receptor antagonists in high-risk patients after laparoscopic surgery.

          Methods

          In this prospective, randomized, double-blinded trial, 109 female nonsmokers scheduled for elective laparoscopic surgery were randomized to receive intravenous 4 mg ondansetron (n = 35), 0.3 mg ramosetron (n = 38), or 75 µg palonosetron (n = 36) before anesthesia. Fentanyl-based intravenous patient-controlled analgesia was administered for 48 h after surgery. Primary antiemetic efficacy variables were the incidence and severity of nausea, the frequency of emetic episodes during the first 48 h after surgery, and the need to use a rescue antiemetic medication.

          Results

          The overall incidence of nausea/retching/vomiting was lower in the palonosetron (22.2%/11.1%/5.6%) than in the ondansetron (77.1%/48.6%/28.6%) and ramosetron (60.5%/28.9%/18.4%) groups. The rescue antiemetic therapy was required less frequently in the palonosetron group than the other groups (P < 0.001). Kaplan-Meier analysis showed that the order of prophylactic efficacy in delaying the interval to use of a rescue emetic was palonosetron, ramosetron, and ondansetron.

          Conclusions

          Single-dose palonosetron is the prophylactic antiemetics of choice in high-risk patients undergoing laparoscopic surgery.

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          Most cited references 30

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          A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers.

          Recently, two centers have independently developed a risk score for predicting postoperative nausea and vomiting (PONV). This study investigated (1) whether risk scores are valid across centers and (2) whether risk scores based on logistic regression coefficients can be simplified without loss of discriminating power. Adult patients from two centers (Oulu, Finland: n = 520, and Wuerzburg, Germany: n = 2202) received inhalational anesthesia (without antiemetic prophylaxis) for various types of surgery. PONV was defined as nausea or vomiting within 24 h of surgery. Risk scores to estimate the probability of PONV were obtained by fitting logistic regression models. Simplified risk scores were constructed based on the number of risk factors that were found significant in the logistic regression analyses. Original and simplified scores were cross-validated. A combined data set was created to estimate a potential center effect and to construct a final risk score. The discriminating power of each score was assessed using the area under the receiver operating characteristic curves. Risk scores derived from one center were able to predict PONV from the other center (area under the curve = 0.65-0.75). Simplification did not essentially weaken the discriminating power (area under the curve = 0.63-0.73). No center effect could be detected in a combined data set (odds ratio = 1.06, 95% confidence interval = 0.71-1.59). The final score consisted of four predictors: female gender, history of motion sickness (MS) or PONV, nonsmoking, and the use of postoperative opioids. If none, one, two, three, or four of these risk factors were present, the incidences of PONV were 10%, 21%, 39%, 61% and 79%. The risk scores derived from one center proved valid in the other and could be simplified without significant loss of discriminating power. Therefore, it appears that this risk score has broad applicability in predicting PONV in adult patients undergoing inhalational anesthesia for various types of surgery. For patients with at least two out of these four identified predictors a prophylactic antiemetic strategy should be considered.
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            A factorial trial of six interventions for the prevention of postoperative nausea and vomiting.

             ,  Ina Vedder,  O. M. Abdalla (2004)
            Untreated, one third of patients who undergo surgery will have postoperative nausea and vomiting. Although many trials have been conducted, the relative benefits of prophylactic antiemetic interventions given alone or in combination remain unknown. We enrolled 5199 patients at high risk for postoperative nausea and vomiting in a randomized, controlled trial of factorial design that was powered to evaluate interactions among as many as three antiemetic interventions. Of these patients, 4123 were randomly assigned to 1 of 64 possible combinations of six prophylactic interventions: 4 mg of ondansetron or no ondansetron; 4 mg of dexamethasone or no dexamethasone; 1.25 mg of droperidol or no droperidol; propofol or a volatile anesthetic; nitrogen or nitrous oxide; and remifentanil or fentanyl. The remaining patients were randomly assigned with respect to the first four interventions. The primary outcome was nausea and vomiting within 24 hours after surgery, which was evaluated blindly. Ondansetron, dexamethasone, and droperidol each reduced the risk of postoperative nausea and vomiting by about 26 percent. Propofol reduced the risk by 19 percent, and nitrogen by 12 percent; the risk reduction with both of these agents (i.e., total intravenous anesthesia) was thus similar to that observed with each of the antiemetics. All the interventions acted independently of one another and independently of the patients' baseline risk. Consequently, the relative risks associated with the combined interventions could be estimated by multiplying the relative risks associated with each intervention. Absolute risk reduction, though, was a critical function of patients' baseline risk. Because antiemetic interventions are similarly effective and act independently, the safest or least expensive should be used first. Prophylaxis is rarely warranted in low-risk patients, moderate-risk patients may benefit from a single intervention, and multiple interventions should be reserved for high-risk patients. Copyright 2004 Massachusetts Medical Society
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              Risk factors for postoperative nausea and vomiting.

               Tong Gan (2006)
              Knowledge of postoperative nausea and vomiting (PONV) risk factors allows anesthesiologists to optimize the use of prophylactic regimens. Modern PONV risk research began in the 1990s with publication of studies using logistic regression analysis to simultaneously identify multiple independent PONV predictors and publication of meta-analyses and systematic reviews. This literature shows that female gender post-puberty, nonsmoking status, history of PONV or motion sickness, childhood after infancy and younger adulthood, increasing duration of surgery, and use of volatile anesthetics, nitrous oxide, large-dose neostigmine, or intraoperative or postoperative opioids are well established PONV risk factors. Possible risk factors include history of migraine, history of PONV or motion sickness in a child's parent or sibling, better ASA physical status, intense preoperative anxiety, certain ethnicities or surgery types, decreased perioperative fluids, crystalloid versus colloid administration, increasing duration of anesthesia, general versus regional anesthesia or sedation, balanced versus total IV anesthesia, and use of longer-acting versus shorter-acting opioids. Early-phase menstruation, obesity and lack of supplemental oxygen are disproved risk factors. Current risk scoring systems have approximately 55%-80% accuracy in predicting which patient groups will suffer PONV. Further research examining genetic and under-investigated clinical patient characteristics as potential risk factors, and involving outpatients and children, should improve predictive systems.
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                Author and article information

                Journal
                Korean J Anesthesiol
                Korean J Anesthesiol
                KJAE
                Korean Journal of Anesthesiology
                The Korean Society of Anesthesiologists
                2005-6419
                2005-7563
                June 2013
                24 June 2013
                : 64
                : 6
                : 517-523
                Affiliations
                [1 ]Department of Anesthesiology and Pain Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
                [2 ]Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea.
                Author notes
                Corresponding author: Hae Keum Kil, M.D., Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine, 134, Sinchon-dong, Seodaemun-gu, Seoul 120-752, Korea. Tel: 82-2-2228-2422, Fax: 82-2-312-7185, hkkil@ 123456yuhs.ac
                Article
                10.4097/kjae.2013.64.6.517
                3695249
                23814652
                Copyright © the Korean Society of Anesthesiologists, 2013

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                Categories
                Clinical Research Article

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