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Brazilian Journal of Anesthesiology... 2024End-stage renal diseases patients have a high risk of postoperative nausea and vomiting (PONV), which is multifactorial and need acute attention after renal... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
End-stage renal diseases patients have a high risk of postoperative nausea and vomiting (PONV), which is multifactorial and need acute attention after renal transplantation for a successful outcome in term of an uneventful postoperative period. The study was done to compare the efficacy of palonosetron and ondansetron in preventing early and late-onset PONV in live donor renal transplantation recipients (LDRT).
METHODS
The prospective randomized double-blinded study was done on 112 consecutive patients planned for live donor renal transplantation. Patients of both sexes in the age group of 18...60 years were randomly divided into two groups: Group O (Ondansetron) and Group P (Palonosetron) with 56 patients in each group by computer-generated randomization. The study drug was administered intravenously (IV) slowly over 30.ßseconds, one hour before extubation. Postoperatively, the patients were accessed for PONV at 6, 24, and 72.ßhours using the Visual Analogue Scale (VAS) nausea score and PONV intensity scale.
RESULTS
The incidence of PONV in the study was found to be 30.35%. There was significant difference in incidence of PONV between Group P and Group O at 6.ßhours (12.5% vs. 32.1%, p.ß=.ß0.013) and 72.ßhours (1.8% vs. 33.9%, p.ß<.ß0.001), but insignificant difference at 24.ßhours (1.8% vs. 10.7%, p.ß=.ß0.113). VAS-nausea score was significantly lower in Group P as compared to Group O at a time point of 24.ßhours (45.54.ß...ß12.64 vs. 51.96.ß...ß14.70, p.ß=.ß0.015) and 72.ßhours (39.11.ß...ß10.32 vs. 45.7.ß...ß15.12, p.ß=.ß0.015).
CONCLUSION
Palonosetron is clinically superior to ondansetron in preventing early and delayed onset postoperative nausea and vomiting in live-related renal transplant recipients.
Topics: Male; Female; Humans; Adolescent; Palonosetron; Ondansetron; Postoperative Nausea and Vomiting; Antiemetics; Kidney Transplantation; Prospective Studies; Double-Blind Method
PubMed: 34411635
DOI: 10.1016/j.bjane.2021.07.027 -
Oncology (Williston Park, N.Y.) Aug 2016Chemotherapy-induced nausea and vomiting (CINV) remains an important adverse effect of cancer therapy. The goal of CINV prophylaxis is to reduce the morbidity associated... (Review)
Review
Chemotherapy-induced nausea and vomiting (CINV) remains an important adverse effect of cancer therapy. The goal of CINV prophylaxis is to reduce the morbidity associated with nausea and vomiting, as well as to preserve quality of life, while maintaining the desired chemotherapy regimen. The US Food and Drug Administration has recently approved new therapies for prevention of CINV, including the neurokinin-1 (NK1) receptor antagonist rolapitant and the fixed-dose combination of the second-generation 5-hydroxytryptamine type 3 receptor antagonist palonosetron with the novel NK1 receptor antagonist netupitant. Alternative agents, like the atypical antipsychotic olanzapine, have also expanded the options available for preventing delayed and refractory CINV. Consensus guidelines for prevention of CINV from several organizations are generally consistent with one another and are updated based on expert review of available clinical trial data. This article will address changes in CINV guidelines over the past 5 years and provide updates on recently approved agents and agents that are expected to be approved, based on published phase III trials. It will also explore other factors affecting optimal CINV control, including the role of patient-related risk factors and the role of physician adherence to antiemetic guidelines in reducing the residual risk of CINV.
Topics: Humans; Postoperative Nausea and Vomiting
PubMed: 27539626
DOI: No ID Found -
Turkish Journal of Anaesthesiology and... Oct 2021Post-operative nausea and vomiting is a frequent complication following anaesthesia. We compared the efficacy and safety of intravenous palonosetron and intravenous...
Efficacy of Palonosetron and Dexamethasone for Prevention of Post-operative Nausea and Vomiting in Female Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomised Double-Blind Trial.
OBJECTIVE
Post-operative nausea and vomiting is a frequent complication following anaesthesia. We compared the efficacy and safety of intravenous palonosetron and intravenous dexamethasone as prophylactic antiemetic in patients undergoing laparoscopic cholecystectomy.
METHODS
After obtaining institutional ethical committee approval, 100 adult female patients undergoing laparoscopic cholecystectomy were randomised to receive 4mg dexamethasone (group I, n ¼ 50) or 0.075 mg palonosetron (group II, n ¼ 50) intravenously (IV) over 2-5 minutes prior to induction of anaesthesia. Standard anaesthetic technique was followed, and the residual neuromuscular block was antagonised at theend of the procedure. A single anaesthesiologist assessed all the cases for post-operative nausea and vomiting (PONV) for 24 hours. The complete response rate and the overall patient satisfaction were noted. If patient experienced PONV, injection metoclopramide 10 mg was given as rescue antiemetic IV.
RESULTS
A total of six patients had vomiting within 6 hours (four patients in groups I and two patients in group II), whereas none had vomiting after 6 hours (P ¼ .39). Complete response rate was 88 and 90% in both group I and group II. Three patients in both group I and group II required rescue antiemetics. Ninety-two percent patients were completely satisfied in group I, while 96% patients were fully satisfied in group II.
CONCLUSION
Intravenous administration of palonosetron (0.075 mg) is as effective as dexamethasone (4 mg) as prophylactic antiemetic without any untoward side effects for female patients undergoing laparoscopic cholecystectomy.
PubMed: 35110042
DOI: 10.5152/TJAR.2021.191 -
Anesthesia, Essays and Researches 2016Postoperative nausea and vomiting (PONV) is a common occurrence after laparoscopic surgeries. A number of pharmacological agents (antihistamines, butyrophenones,...
BACKGROUND
Postoperative nausea and vomiting (PONV) is a common occurrence after laparoscopic surgeries. A number of pharmacological agents (antihistamines, butyrophenones, dopamine receptor antagonists) have been tried of which the 5-hydroxytryptamine type 3 receptor antagonists are devoid of most side effects and highly effective in prevention and treatment of PONV. Thus, we evaluated the effectiveness of granisetron and palonosetron in prevention of PONV after laparoscopic surgeries under general anesthesia.
AIMS
We conducted a study to evaluate the effectiveness of granisetron and palonosetron, to compare the duration of action and side effects if any, in patients undergoing elective laparoscopic surgery under general anesthesia.
SETTINGS AND DESIGN
This was a prospective, randomized, double-blinded, comparative study. Sixty patients (18-65 years of age) of the American Society of Anesthesiologists Grade I and II undergoing elective laparoscopic surgeries were considered.
MATERIALS AND METHODS
They were randomly allocated into one of the two groups (Group G and Group P) of thirty patients each. Group G received injection granisetron 0.05 mg/kg; Group P received injection palonosetron 1.5 mcg/kg intravenous bolus 30 min before the induction of anesthesia.
STATISTICAL TESTS
All statistical analyses were performed using the SPSS statistical package version 18.0 (Chicago: SPSS Inc). Two independent sample -test was used for quantitative data, and the χ or Fisher's exact test was used for qualitative data. A difference was regarded as statistically significant at a < 0.05.
RESULTS
The need for rescue antiemetic was significantly lower in Group P in the 24-72 h postoperative period (ρ - 0.007). The PONV score was significantly less in Group P in the same period (ρ - 0.008). The incidence of side effects was statistically insignificant in both the groups (ρ - 0.999).
CONCLUSION
Prophylactic therapy with palonosetron is more effective than granisetron in the prevention of PONV after laparoscopic surgeries under general anesthesia.
PubMed: 27746523
DOI: 10.4103/0259-1162.191121 -
Journal of Anaesthesiology, Clinical... 2019The present study evaluated the effects of two 5-HT3 serotonin receptor antagonists; granisetron and palonosetron on hemodynamics, sensory, and motor blockade induced by...
Comparison of IV granisetron and IV palonosetron on hemodynamics and sensory and motor block after spinal anesthesia with hyperbaric bupivacaine in patients undergoing abdominal hysterectomy.
BACKGROUND AND AIMS
The present study evaluated the effects of two 5-HT3 serotonin receptor antagonists; granisetron and palonosetron on hemodynamics, sensory, and motor blockade induced by intrathecal bupivacaine in patients undergoing abdominal hysterectomy.
MATERIAL AND METHODS
In total, 126 female patients (ASA I and II physical status) undergoing abdominal hysterectomy under spinal anesthesia with intrathecal bupivacaine were randomly divided into three groups out of which 40 patients in each group were evaluated for final outcome. Group G received intravenous 1 mg granisetron, group P received intravenous palonosetron 0.075 mg, and group C received intravenous normal saline. Study drug was given 5 min before the spinal anesthesia. Systolic, diastolic and mean arterial blood pressure, heart rate, sensory and motor blockade were assessed.
RESULTS
The systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate showed no significant differences among the three groups. Time to reach peak sensory block and modified Bromage 3 motor block, time to two segmental regression of sensory block, and motor regression to modified Bromage score of 0 were not statistically different among the three groups. Although statistically significant early regression of sensory block to segment S1 was seen in group G as compared to group P and group C, it was of no clinical significance. The incidence of nausea and vomiting was significantly lower in group G and P.
CONCLUSION
Intravenous administration of granisetron and palonosetron before intrathecal bupivacaine does not attenuate the hemodynamic changes in patients undergoing abdominal hysterectomy. Further, both 5-HT3 receptors antagonists do not have clinically significant effects on the spinal blockade produced by hyperbaric bupivacaine.
PubMed: 31303705
DOI: 10.4103/joacp.JOACP_334_17 -
Journal of Pharmaceutical Health Care... 2018Antiemetic effects and safety of granisetron or palonosetron alone and in combination with a corticosteroid against chemotherapy-induced nausea and vomiting (CINV) were...
BACKGROUND
Antiemetic effects and safety of granisetron or palonosetron alone and in combination with a corticosteroid against chemotherapy-induced nausea and vomiting (CINV) were retrospectively evaluated in patients with Hodgkin lymphoma receiving adriamycin, bleomycin, vinblastine, and dacarbazine (ABVD) therapy.
METHODS
A total of 39 patients were eligible for this study. Before ABVD therapy, granisetron or palonosetron was intravenously administered with or without a corticosteroid (dexamethasone or hydrocortisone) and aprepitant. The proportions of patients with complete control (CC) during the overall (0-120 h after the start of ABVD therapy), acute (0-24 h) and delayed (24-120 h) phases were evaluated. CC was defined as no vomiting and no use of antiemetic rescue medication with only grade 0-1 nausea.
RESULTS
Granisetron and palonosetron were administered in 21 and 18 patients, respectively. The CC rate during the acute, delayed and overall phases was not statistically different between the two groups. The CINV was completely controlled during overall phase in 58.3% of patients receiving granisetron or palonosetron in combination with a corticosteroid, whereas in 11.1% of those without co-treatment of a corticosteroid ( < 0.05). There were significantly higher frequencies of anorexia, leucopenia and neutropenia in the palonosetron group. There is a statistically significant difference in the frequency of febrile neutropenia between presence and absence of a corticosteroid ( = 0.024).
CONCLUSION
These findings suggested that a combination use of a corticosteroid with a 5-HT receptor antagonist was preferable for CINV control in patients with Hodgkin lymphoma receiving ABVD therapy, although the careful management of febrile neutropenia is required.
TRIAL REGISTRATION
The study approval numbers in the institution; 24-12 and 24-359. Registered April 17, 2012 and June 21, 2012.
PubMed: 29345696
DOI: 10.1186/s40780-017-0097-4 -
Anesthesia, Essays and Researches 2019Laparoscopic cholecystectomy (LC) is associated with high risk of postoperative nausea and vomiting (PONV) if no prophylactic antiemetic is used.
Comparison of Palonosetron and Dexamethasone with Ondansetron and Dexamethasone to Prevent Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy.
BACKGROUND
Laparoscopic cholecystectomy (LC) is associated with high risk of postoperative nausea and vomiting (PONV) if no prophylactic antiemetic is used.
AIMS
The study compared prophylactic palonosetron and dexamethasone with ondansetron and dexamethasone in patients undergoing LC.
SETTING AND DESIGN
This prospective, double-blinded, randomized, controlled study was conducted at a tertiary care center.
MATERIALS AND METHODS
The study was carried out in 86 patients who underwent LC. The patients were randomly assigned to following study groups: Group 1 who received palonosetron (0.75 mg) with dexamethasone (8 mg) and Group II who received ondansetron (4 mg) with dexamethasone (8 mg). Patients were observed for nausea with visual analog scale and vomiting episode during 48 h postoperative follow-up.
STATISTICAL ANALYSIS USED
Data were analyzed as mean, standard deviation, percentage, and number. The following statistical tests were used: paired or unpaired -test, Mann-Whitney test, Chi-square test, and repeated ANOVA test.
RESULTS
There was no statistically significant difference in heart rate, mean arterial pressure, and oxygen saturation from baseline. During 48 h follow-up, the incidence of nausea, vomiting, and PONV was higher in Group II, but the difference was not statistically significant. The total dose of rescue antiemetic was 2.14 ± 4.15 mg in Group I and 5.00 ± 8.62 mg in Group II patients ( = 0.058). Headache was present in three patients in Group I and two patients of Group II.
CONCLUSION
The palonosetron with dexamethasone is comparable to ondansetron with dexamethasone in the prevention of PONV in patients undergoing LC.
PubMed: 31198253
DOI: 10.4103/aer.AER_21_19 -
Romanian Journal of Anaesthesia and... Jul 2021For the prevention of PONV, we evaluated the efficacy of palonosetron compared with ondansetron along with dexamethasone in patients undergoing laparoscopic...
Antiemetic Efficacy of Palonosetron Compared with the Combination of Ondansetron and Dexamethasone for Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynaecological Surgery.
BACKGROUND AND AIMS
For the prevention of PONV, we evaluated the efficacy of palonosetron compared with ondansetron along with dexamethasone in patients undergoing laparoscopic gynaecological surgery.
METHODS
A total of 84 adults, posted for elective laparoscopic surgeries under general anaesthesia were included in the study. The patients were randomly allocated to two groups (n = 42 each). Immediately after induction, patients in the first group (group I) received 4 mg ondansetron with 8 mg dexamethasone, and patients in the second group (group II) received 0.075 mg palonosetron. Any incidences of nausea and/or vomiting, the requirement of rescue antiemetic, and side effects were recorded.
RESULTS
In group I, 66.67% of the patients had an Apfel score of 2, and 33.33% of the patients had a score of 3. In group II, 85.71% of patients had an Apfel score of 2, and 14.29% of the patients had a score of 3. At 1, 4, and 8 hours, the incidence of PONV was comparable in both groups. At 24 hours there was a significant difference in the incidence of PONV in the group treated with ondansetron with dexamethasone combination (4/42) when compared to the palonosetron group (0/42). The overall incidence of PONV was significantly higher in group I (23.81%: ondansetron and dexamethasone combination) than in group II (7.14%: palonosetron). The need for rescue medication in group I was significantly high. Conclusion: Palonosetron was more efficacious compared to the combination of ondansetron and dexamethasone for preventing PONV for laparoscopic gynaecological surgery.
PubMed: 36846536
DOI: 10.2478/rjaic-2021-0003 -
Anesthesia, Essays and Researches 2014Postoperative nausea and vomiting is commonly associated with adverse consequences and hamper the postoperative recovery in spite of the availability of many antiemetic...
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.
PubMed: 25886226
DOI: 10.4103/0259-1162.134503 -
Biomedical Papers of the Medical... Jun 2023Postdischarge nausea and vomiting (PDNV) cause substantial pediatric morbidity with potentially serious postoperative complications. However, few studies have addressed... (Review)
Review
Postdischarge nausea and vomiting (PDNV) cause substantial pediatric morbidity with potentially serious postoperative complications. However, few studies have addressed PDNV prevention and treatment in pediatric patients. Here we searched the literature and processed it in a narrative review describing PDNV incidence, risk factors, and management in pediatric patients.. A successful strategy for reducing PDNV considers both the pharmacokinetics of the antiemetic agents and the principle of multimodal prophylaxis, utilizing agents of different pharmacologic classes. Since many highly effective antiemetic agents have relatively short half-lives, a different approach must be used to prevent PDNV. A combination of oral and intravenous medications with longer half-lives, such as palonosetron or aprepitant, can be used. In addition, we designed a prospective observational study with the primary objective of determining PDNV incidence. In our study group of 205 children, the overall PDNV incidence was 14.6% (30 of 205), including 21 children suffering from nausea and 9 suffering from vomiting.
Topics: Humans; Child; Antiemetics; Postoperative Nausea and Vomiting; Aftercare; Patient Discharge; Prospective Studies; Observational Studies as Topic
PubMed: 37222143
DOI: 10.5507/bp.2023.020