Anesthesia: Essays and Researches Improved prophylaxis of postoperative nausea vomiting: Palonosetron a novel antiemetic (original) (raw)
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Anesthesia & Analgesia, 2008
The Palonosetron 04-07 Study Group BACKGROUND: We designed this multicenter, randomized, double-blind study to assess the efficacy and safety of three doses of palonosetron, compared with placebo, on the incidence and severity of postoperative nausea and vomiting (PONV) in inpatients for 72 h after surgery. METHODS: Female patients undergoing either elective gynecological or breast surgery were stratified according to two additional PONV risk factors: nonsmoking status and history of PONV and/or motion sickness. Five hundred forty-four patients with one or both of these risk factors were randomized to receive one of the three doses of IV palonosetron (0.025 mg, 0.050 mg, 0.075 mg) or placebo immediately before induction of anesthesia. The primary efficacy end-point was complete response (CR: no emesis and no use of rescue medications) evaluated at the 0-24 and 24-72 h time intervals after surgery. RESULTS: CR rates for placebo and palonosetron 0.075 mg were 36% and 56% for 0-24 h (P ϭ 0.001), 52% and 70% for 24-72 h (P ϭ 0.002) and 36% and 52% (P ϭ 0.010) for the 0-72 h postoperative interval. Palonosetron 0.075 mg was associated with less intense nausea (e.g., toward "mild" or "none") versus placebo during the 0-24 h (P Ͻ 0.001) time interval and significantly delayed median time to emesis (P ϭ 0.002) and treatment failure (P ϭ 0.004). Although CR rates for both the 0.025 mg and 0.050 mg palonosetron doses were not statistically superior to placebo for the 0-24 h or 24-72 h periods, both lower doses reduced nausea severity during the 0-24 h period (P ϭ 0.040 and P ϭ 0.004). CONCLUSION: A single 0.075-mg IV dose of palonosetron effectively reduced the severity of nausea and delayed the time to emesis and treatment failure in the inpatient surgical setting; lower doses were not as effective.
2013
2 Assistant professor , 5 Resident, 6 Senior resident, 7 ABSTRACT Background: Palonosetron is a second generation 5-Hydroxytryptamine-3 receptor antagonist with longer half- life and higher receptor binding affinity than Ondansetron. Aims & objective: To assess the efficacy and safety profile of intravenous palonosetron cpompared to the ondansetron for prevention of post-operative nausea and vomiting (PONV) under general anesthesia. Methodology: A prospective, randomized, placebo-controlled, double-blind study was conducted in 90 patients aged 20-60 years, undergoing major surgeries. Group I (n=30) received placebo injection; Group II (n=30) received inj. ondansetron 8 mg and Group III (n=30) received inj. palonosetron 0.075 mg IV. In the operating room, the study drugs were given IV in equal volume of 4ml, before inducing the patients. In postoperative period each patient was observed for retching, nausea and/or vomiting at 30 min; and then at 1, 2, 6, 12 and 24 hours. Any side eff...
Biomedical and Pharmacology Journal
Background Post operative nausea vomiting (PONV) is distressing for patient as well as clinician as it affects post-operative care and recovery substantially. Causes of PONV are multi factorial which are primarily categorized into patient related factors, pre- surgical factors and post-surgical factors. There are several classes of drugs that constitute basic of anti-emetic therapy. Primary objective of the study is to assess the efficacy and safety of intravenous (IV) Palonosetron in preventing post operative nausea vomiting (PONV) in comparison with IV ondansetron. Methodology This is a double blinded randomized controlled study conducted during the period of January 2015 to February 2016 in patients with ASA (American Society of Anesthesiologist) grade I category who underwent surgical intervention under general anaesthesia. Both male and female patients in the age range of 15-60 years with ASA grade I status and willing to give written informed consent were recruited for the stu...
Anesthesia: Essays and Researches, 2014
Background: Postoperative nausea and vomiting is commonly associated with adverse consequences and hamper the postoperative recovery in spite of the availability of many antiemetic drugs and regimens for its prevention. The study was aimed to compare the prophylactic effects of intravenously administered palonosetron, ondansetron, and granisetron on prevention of postoperative nausea and vomiting after general anesthesia. Materials and Methods: This prospective, double-blind study, comprised 120 adult consented patients of ASA grade I and II of either gender, was carried out after approval of Institutional Ethical Committee. Patients were randomized into three equal groups of 40 patients each in double-blind manner. Group P received inj. palonosetron (0.075 mg), group O received inj. ondansetron (4 mg), and group G received inj. granisetron (2 mg) intravenously five minutes before induction of anesthesia. The need for rescue antiemetic, episode of postoperative nausea and vomiting, and side effects were observed for 12 hours in the post-anesthesia care unit. At the end of study, results were compiled and statistical analysis was done by using ANOVA, Chi-square test, and Kruskal Wallis Test. Value of P < 0.05 was considered significant. Results: The incidence of nausea and vomiting was maximal during the first four hours postoperatively. The complete control of postoperative nausea and vomiting for first 12 hours was achieved in 30% patients of ondansetron group, 55% patients of granisetron group, and 90% patients of palonosetron group. Safety profile was more with palonosetron. Conclusion: Palonosetron was comparatively highly effective to prevent the PONV after anesthesia due to its prolonged duration of action than ondansetron and granisetron.
American Journal of Therapeutics, 2012
Background: Postoperative nausea and vomiting (PONV) is a common complication after anesthesia and surgery; 5-hydroxytryptamine type 3 (5-HT 3) receptor antagonists have been considered as a first-line therapy. Ramosetron and palonosetron are more recently developed drugs and have greater receptor affinity and a longer elimination halflife compared with older 5-HT 3 receptor antagonists. The purpose of this study was to determine which drug is more effective for preventing PONV between ramosetron and palonosetron. Methods: We enrolled 100 patients undergoing gynecological laparoscopic surgery into this study. The subjects were divided into ramosetron group and palonosetron group. The medications were provided immediately before the induction of anesthesia. The occurrence of nausea and vomiting, severity of nausea according to a visual analogue scale, and rescue anti-emetic drug use were monitored immediately after the end of surgery and at 0-6 h, 6-24 h, and 24-48 h post-surgery. Results: The incidence of vomiting was significantly lower in the palonosetron group than in the ramosetron group during 0-6 h (6% vs 26%, P = 0.012) and 0-48 h (14% vs 34%, P = 0.034). The incidence of nausea and overall PONV, and the use of rescue antiemetic were not significantly different during all time intervals. The severity of nausea was not different between the two groups. Conclusions: In conclusion, the incidence of PONV between the ramosetron and the palonosetron group have not shown the difference during 0-48 h, although palonosetron results in a lower incidence of vomiting during 0-6 h post-surgery.
BMC pharmacology & toxicology, 2014
This study compared palonosetron and ondansetron as rescue medications for postoperative nausea and vomiting (PONV) in patients who received prophylactic ondansetron. Although guidelines recommend use of an agent from a different class when prophylaxis has failed, palonosetron has unique properties relative to other serotonin 5-HT3 receptor antagonists. Prior trials assessing its use for rescue have had conflicting results. Although palonosetron has compared favorably with ondansetron for PONV prevention, the drugs have not been compared in the rescue setting of failure of 5-HT3 receptor antagonist prophylaxis. This was a randomized, open-label, multicenter trial comparing the efficacy and safety of intravenous palonosetron 0.075 mg and intravenous ondansetron 4 mg in patients experiencing PONV following laparoscopic abdominal or gynecological surgery despite prophylactic ondansetron. Of 239 patients screened, 220 were enrolled and 98 were treated for PONV: 48 and 50 in the palonose...
Background: Post-operative nausea and vomiting (PONV) is commonly seen in female patients undergoing abdominal surgeries under general anaesthesia. In this randomized double blind prospective study, efficacy of ondansetron and palonosetron for prevention of PONV following abdominal surgeries under general anaesthesia was compared. Methods: 60 female patients undergoing elective abdominal surgery were randomly allocated to one of the two groups of 30 patients each. Group O patients received injection Ondansetron 4mg and Group P patients received injection Palonosetron 75mcg intravenously 15 minutes before induction. All episodes of PONV within 72 hours after induction of anaesthesia were recorded. Statistical Analysis: Statistical analysis was done using two sample t test. Results: The incidence of complete response (no PONV, no rescue medication required) during 0-6 hours in post-operative period was 93.33% in patients of group O and 86.67% in patients of group P. But the incidence of complete response during 6-24 hrs of post-operative period was only 73.33% in patients of group O while it was 93.33% in patients of group P. During 24-48 hours in postoperative period incidence of complete response was only 66.67% in group O while it was 96.67 % in group P. And during 48-72 hrs in postoperative period incidence of complete response was 86.67% in patients of group O and 96.67% in patients of group P. Rescue antiemetic in the form of inj. Metoclopramide was given in the patients who had vomiting. Conclusion: Single dose of Palonosetron was more effective for prevention of nausea and vomiting in comparison to Ondansetron after 6 hrs in post-operative period in abdominal surgeries.
https://www.ijhsr.org/IJHSR\_Vol.8\_Issue.5\_May2018/IJHSR\_Abstract.015.html, 2018
Background: Postoperative nausea and vomiting is an unpleasant and distressing adverse effect after anaesthesia and surgery which may result in wound dehiscence, bleeding, dehydration, electrolyte imbalance, pulmonary aspiration of gastric contents and delayed hospital discharge leading more expenses to the patient. Multiple studies were being conducted to find out an amicable solution to this problem. Aims and Objectives: The study was to compare the efficacy of preoperative palonosetron plus dexamethasone combination therapy versus dexamethasone monotherapy for the prevention of postoperative nausea and vomiting (PONV) following any elective surgery under general anaesthesia. Methods: It was a prospective, randomized controlled and double blind study where 100 patients of either sex, ASA I & II, aged 18-65 years were enrolled to receive either10 mg dexamethasone and 0.075 Palonosetron or 10 mg dexamethasone (total volume of 5 ml made with normal saline) slow IV, 10 minutes before induction of anaesthesia. Results: During the first 24 hours postoperative, the incidence of nausea, retching and vomiting in the palonosetron plus dexamethasone group were 20%, 18% and 16% respectively and lesser as compared to 40%, 30% and 38% in the dexamethasone group alone, with p=0.04, p=0.24 and p=0.02 respectively. Complete response was more in the palonosetron plus dexamethasone group (80% versus 60%) with p=0.04 Conclusion: The study showed that prophylactic administration of intravenous palonosetron plus dexamethasone can effectively control postoperative nausea and vomiting as compared to dexamethasone alone.
IP Innovative Publication Pvt. Ltd., 2018
Introduction and Aims: Postoperative nausea and vomiting (PONV) are very common and distressing adverse events after general anaesthesia. Palonosetron and ramosetron are newer, second generation, selective 5-HT3 receptor antagonists. The present study was carried out to compare the efficacy and safety of palonosetron and ramosetron for prevention of postoperative nausea and vomiting (PONV) over the period of 72 hours in patients undergoing for laparoscopic surgery under general anaesthesia. Materials and Methods: 80 patients of ASA class I and II undergoing for various laparoscopic surgeries were randomly allocated into 2 groups of 40 each, to receive Inj. palonosetron 75 ?g (group P) or Inj. Ramosetron 0.3 mg (group R). Patients were monitored for emesis, severity of nausea, requirement of rescue antiemetic and complete response up to 72 hours (0-6, 6-24, 24-72) post operatively. Results: During 0-6 hours, severity of PONV was comparable in both drug groups but during 24-72 hours, PONV score 2 was observed in 5% and 17.5% of patients of group P and group R respectively (p=0.027). While score 3 was observed in 15% of patients of group R and none of the patients of group P (p=0.01). On comparison of complete response between Group P and Group R, at 0-6 hours response was almost equal but during 6-24 hours and 24-72 hours number of patient having complete response were more in Group P (97.5% and 82.5%) as compared to Group R (65% and 57% respectively). Conclusion: Palonosetron given as a prophylaxis for post-operative nausea and vomiting (PONV) in patients undergoing for laparoscopic surgeries seems to have better antiemetic effect over ramosetron. Keywords: PONV, Palonosetron, Ramosetron, Laparoscopic surgery.
ABSTRACT Background: Postoperative nausea and vomiting (PONV) is a major complication in patients who undergo surgery under general anaesthesia. Various drug regimens and antiemetic interventions have been tried from time-to-time for prevention of PONV but with a variable success rate. This study compares the safety and efficacy of ondansetron and palonosetron in preventing PONV in such patients. Methods: A prospective study was conducted in 60 ASA grades - I and II patients of either sex, aged between 20 to 50 years, scheduled for elective surgery under general anaesthesia, 30 of who received 4 mg ondansetron and the remaining 30 received 0.05 mg palonosetron intravenously 5 minutes before induction of anaesthesia. Postoperatively they were observed for 24 hours for complete response, any episodes of nausea and vomiting, their severity, need for rescue antiemetic and side effects. After the study, results were compiled and the data was analysed using Student’s T test. P value <0.05 was considered significant. Results: PONV was 40% in ondansetron group and 17% in palonosetron group (p >0.5). Complete antiemetic response was 60% in ondansetron group and 83% in palonosetron group. There was no significant statistical difference between both the groups in causing headache (p >0.5) and dizziness (p >0.05). Conclusions: Our study concludes that the antiemetic efficacy is comparable for both ondansetron and palonosetron in the given doses in preventing PONV and none superior. Both the study drugs had almost the same adverse effect profile.