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Medicine Aug 2021Postoperative nausea and vomiting (PONV) is an undesirable complication in patients undergoing general anesthesia. Combination therapy via different mechanisms of action...
BACKGROUND
Postoperative nausea and vomiting (PONV) is an undesirable complication in patients undergoing general anesthesia. Combination therapy via different mechanisms of action for antiemetic prophylaxis has been warranted for effective treatment of PONV. This study was designed to compare the prophylactic antiemetic effect between midazolam combined with palonosetron (group MP) and palonosetron alone (group P) after laparoscopic cholecystectomy surgeries.
METHODS
A prospective randomized controlled trial was investigated in non-smoking female. Eighty-eight patients were randomly divided into 2 groups with 44 patients each. Group MP received 0.05 mg/kg of midazolam intravenously before induction of anesthesia whereas group P received the same volume of normal saline. Immediately after anesthetic induction, 0.075 mg of palonosetron was administered to both the groups. The incidence and severity of PONV were assessed during 2 time intervals (0-2 hours, 2-24 hours), postoperatively.
RESULTS
The incidence of PONV during 24 hours after surgery was lower in group MP as compared to group P. There was also a significant difference in the use of rescue antiemetics. The severity of nausea was significantly lower in group MP as compared to group P, in the initial 2 hours after surgery. The incidence of side effects was similar between the 2 groups.
CONCLUSION
In the prevention of PONV, midazolam combined with palonosetron, administered during induction of anesthesia was more effective as compared to palonosetron alone.
Topics: Adjuvants, Anesthesia; Adult; Antiemetics; Cholecystectomy, Laparoscopic; Female; Humans; Male; Midazolam; Middle Aged; Palonosetron; Postoperative Nausea and Vomiting; Prospective Studies; Republic of Korea
PubMed: 34414984
DOI: 10.1097/MD.0000000000026997 -
JCO Global Oncology Jan 2024The effectiveness of a dexamethasone (DEX)-free regimen for chemotherapy-induced nausea and vomiting (CINV) prophylaxis in patients receiving highly emetogenic... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
The effectiveness of a dexamethasone (DEX)-free regimen for chemotherapy-induced nausea and vomiting (CINV) prophylaxis in patients receiving highly emetogenic chemotherapy (HEC) is not known.
METHODS
This was a double-blind, phase III trial designed to show the noninferiority of a DEX-free regimen (olanzapine, palonosetron, and fosaprepitant [OPF]) compared with the DEX-containing regimen (olanzapine, palonosetron, and DEX [OPD]). Chemotherapy-naïve patients age 18-80 years receiving single-day HEC were randomly assigned 1:1 to receive either the OPD regimen or the OPF regimen. The primary objective was to compare complete response (CR) rates for vomiting during the overall period (start of chemotherapy to 120 hours). Secondary objectives included CR for vomiting during the acute period (0-24 hours) and delayed period (24-120 hours), CR for nausea, and comparison of toxicities and patient-reported outcomes.
RESULTS
Three hundred forty-six patients received the study interventions, 174 in the OPD arm and 172 in the OPF arm. The DEX-free OPF arm had significantly higher CR rates for vomiting compared with the DEX-containing OPD arm in acute (94.7% 85.6%; < .004), delayed (81.9% 50.5%; < .001), and overall (79.6% 48.8%; < .001) periods. For nausea, CR rates in the OPF arm were higher in delayed (53.4% 39.6%; = .009) and overall (50.5% 39.1%; = .031) periods but not in the acute period (77.9% 81.6%; = .39). Fatigue ( = .009) and drowsiness ( = .002) were more in the OPF arm in the acute period and insomnia ( < .001) in the OPD arm in the overall period.
CONCLUSION
This study shows that a DEX-free OPF regimen is efficacious and should be considered a standard option for acute and delayed CINV prophylaxis for HEC.
Topics: Humans; Adolescent; Young Adult; Adult; Middle Aged; Aged; Aged, 80 and over; Antiemetics; Palonosetron; Olanzapine; Vomiting; Nausea
PubMed: 38237092
DOI: 10.1200/GO.23.00301 -
EClinicalMedicine Jul 2022Despite significant progress in the prevention of chemotherapy-induced nausea and vomiting (CINV) by using dexamethasone combined with palonosetron for patients who...
Aprepitant plus palonosetron versus dexamethasone plus palonosetron in preventing chemotherapy-induced nausea and vomiting in patients with moderate-emetogenic chemotherapy: A randomized, open-label, phase 3 trial.
BACKGROUND
Despite significant progress in the prevention of chemotherapy-induced nausea and vomiting (CINV) by using dexamethasone combined with palonosetron for patients who received moderate-emetogenic chemotherapy (MEC), some of these patients still suffer from CINV. We evaluated whether aprepitant combined with palonosetron can improve the efficacy in the prevention of CINV in patients receiving MEC.
METHODS
This was a single-centre, open-label, phase III, randomized controlled trial, which was done at the Sixth Affiliated Hospital of Sun Yat-sen University of China. The registered patients planned to receive mFOLFOX6 (oxaliplatin, leucovorin, and 5-fluorouracil) but had not received any chemotherapy previously. The patients were randomized in a 1:1 ratio to the aprepitant group (aprepitant 125 mg orally on day 1, 80 mg on day 2-3) and the dexamethasone group (dexamethasone 10 mg intravenously on day 1, 5 mg on days 2 and 3), both groups with palonosetron 0.25 mg intravenously on day 1. The primary endpoint was the proportion of patients who achieved a complete response (CR), defined as the absence of vomiting and no use of rescue medications in the overall phase (0-120 h). The primary outcome and safety were assessed in the modified intention-to-treat population, which excluded all patients who used estazolam within 24 h before registration and those who refused to keep a diary documenting the severity of nausea, frequency of vomiting, and the use of rescue therapy. This trial is registered with ClinicalTrials.gov, NCT02909478.
FINDINGS
Between Sep 1, 2017, and Oct 23, 2019, 320 patients were enrolled, and 315 patients were evaluated. The proportion of patients who achieved CR was significantly higher with aprepitant than that noted with dexamethasone in the overall phase (88.8% vs. 74.2%; = 0.0010; rate difference, RD 15%, 95% CI, 6% to 23%) and in the delayed phase (25-120 h), 90.6% vs. 75.5%, ( < 0.0001; RD 15%, 95%CI, 7% to 23%). No significant difference of CR rate was observed in the acute phase (0-24 h), 93.8% vs. 93.5%, ( = 0.94; RD 0%, 95% CI, -5% to 6%)). In the overall phase, the incidence of insomnia ( < 0.0010), dyspepsia ( = 0.038), and flushing ( = 0.0010) reported by the patients was significantly higher in the dexamethasone group than that in the aprepitant group.
INTERPRETATION
Aprepitant combined with palonosetron is superior to dexamethasone combined with palonosetron in patients who received the MEC regimen mFOLFOX6 in terms of preventing CINV.
FUNDING
The National Key R&D Program of China (2019YFC1316000) and the National Natural Science Foundation of China (81974369).
PubMed: 35747189
DOI: 10.1016/j.eclinm.2022.101480 -
The Cochrane Database of Systematic... Feb 2016Nausea and vomiting remain a problem for children undergoing treatment for malignancies despite new antiemetic therapies. Optimising antiemetic regimens could improve... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Nausea and vomiting remain a problem for children undergoing treatment for malignancies despite new antiemetic therapies. Optimising antiemetic regimens could improve quality of life by reducing nausea, vomiting, and associated clinical problems. This is an update of the original systematic review.
OBJECTIVES
To assess the effectiveness and adverse events of pharmacological interventions in controlling anticipatory, acute, and delayed nausea and vomiting in children and young people (aged less than 18 years) about to receive or receiving chemotherapy.
SEARCH METHODS
Searches included the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, LILACS, PsycINFO, conference proceedings of the American Society of Clinical Oncology, International Society of Paediatric Oncology, Multinational Association of Supportive Care in Cancer, and ISI Science and Technology Proceedings Index from incept to December 16, 2014, and trial registries from their earliest records to December 2014. We examined references of systematic reviews and contacted trialists for information on further studies. We also screened the reference lists of included studies.
SELECTION CRITERIA
Two review authors independently screened abstracts in order to identify randomised controlled trials (RCTs) that compared a pharmacological antiemetic, cannabinoid, or benzodiazepine with placebo or any alternative active intervention in children and young people (less than 18 years) with a diagnosis of cancer who were to receive chemotherapy.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted outcome and quality data from each RCT. When appropriate, we undertook meta-analysis.
MAIN RESULTS
We included 34 studies that examined a range of different antiemetics, used different doses and comparators, and reported a variety of outcomes. The quality and quantity of included studies limited the exploration of heterogeneity to narrative approaches only.The majority of quantitative data related to the complete control of acute vomiting (27 studies). Adverse events were reported in 29 studies and nausea outcomes in 16 studies.Two studies assessed the addition of dexamethasone to 5-HT3 antagonists for complete control of vomiting (pooled risk ratio (RR) 2.03; 95% confidence interval (CI) 1.35 to 3.04). Three studies compared granisetron 20 mcg/kg with 40 mcg/kg for complete control of vomiting (pooled RR 0.93; 95% CI 0.80 to 1.07). Three studies compared granisetron with ondansetron for complete control of acute nausea (pooled RR 1.05; 95% CI 0.94 to 1.17; 2 studies), acute vomiting (pooled RR 2.26; 95% CI 2.04 to 2.51; 3 studies), delayed nausea (pooled RR 1.13; 95% CI 0.93 to 1.38; 2 studies), and delayed vomiting (pooled RR 1.13; 95% CI 0.98 to 1.29; 2 studies). No other pooled analyses were possible.Narrative synthesis suggests that 5-HT3 antagonists are more effective than older antiemetic agents, even when these agents are combined with a steroid. Cannabinoids are probably effective but produce frequent side effects.
AUTHORS' CONCLUSIONS
Our overall knowledge of the most effective antiemetics to prevent chemotherapy-induced nausea and vomiting in childhood is incomplete. Future research should be undertaken in consultation with children, young people, and families that have experienced chemotherapy and should make use of validated, age-appropriate measures. This review suggests that 5-HT3 antagonists are effective in patients who are to receive emetogenic chemotherapy, with granisetron or palonosetron possibly better than ondansetron. Adding dexamethasone improves control of vomiting, although the risk-benefit profile of adjunctive steroid remains uncertain.
Topics: Adolescent; Antiemetics; Antineoplastic Agents; Child; Dexamethasone; Drug Therapy, Combination; Humans; Nausea; Neoplasms; Randomized Controlled Trials as Topic; Serotonin Antagonists; Vomiting
PubMed: 26836199
DOI: 10.1002/14651858.CD007786.pub3 -
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 -
Therapeutics and Clinical Risk... 2016As recommended by most recent antiemetic guidelines, the optimal prophylaxis of chemotherapy-induced nausea and vomiting (CINV) requires the combination of 5-HT3... (Review)
Review
As recommended by most recent antiemetic guidelines, the optimal prophylaxis of chemotherapy-induced nausea and vomiting (CINV) requires the combination of 5-HT3 receptor antagonist (RA) with an NK1-RA. Moreover, the major predictors of acute and delayed CINV include: young age, female sex, platinum- or anthracycline-based chemotherapy, nondrinker status, emesis in the earlier cycles of chemotherapy, and previous history of motion/morning sickness. Despite improved knowledge of the pathophysiology of CINV and advances in the availability of active antiemetics, an inconsistent compliance with their use has been reported, thereby resulting in suboptimal control of CINV in several cases. In this scenario, a new anti-emetic drug is now available, which seems to be able to guarantee better prophylaxis of CINV and improvement of adherence to guidelines. In fact, netupitant/palonosetron (NEPA) is a ready-to-use single oral capsule, combining an NK1-RA (netupitant) and a 5-HT3-RA (palonosetron), which is to be taken 1 hour before the administration of chemotherapy, ensuring the coverage from CINV for 5 days. We reviewed the role of NEPA in patients at high risk of CINV receiving highly emetogenic chemotherapy. In these patients, NEPA plus dexamethasone, as compared to standard treatments, achieved superior efficacy in all primary and secondary end points during the acute, delayed, and overall phases, including nausea assessment. Moreover, these results were also achieved in female patients receiving anthracycline plus cyclophosphamide-based chemotherapy. NEPA represents a real step forward in the prophylaxis of CINV.
PubMed: 27354807
DOI: 10.2147/TCRM.S89215 -
Current Therapeutic Research, Clinical... 2019Postoperative nausea and vomiting (PONV) are 2 of the most frequent adverse effects of anesthesia. PONV prolongs hospital stays and also delays the recovery of patients.
BACKGROUND
Postoperative nausea and vomiting (PONV) are 2 of the most frequent adverse effects of anesthesia. PONV prolongs hospital stays and also delays the recovery of patients.
OBJECTIVE
In this study, the effects of ondansetron, tropisetron, and palonosetron on PONV in patients who had undergone middle ear surgeries such as mastoidectomy or tympanoplasty were compared.
METHODS
The study included 165 American Society of Anesthesiologists grade 1 and 2 patients aged 18 to 65 years. Patients were randomized into 3 groups by a closed envelope method. Neither the patients nor the nurses administering the treatments knew which patient belonged to which group. The anesthetic technique was standardized for all groups. During skin closure, 0.075 mg palonosetron, 5 mg tropisetron, and 8 mg ondansetron were administered intravenously to the palonosetron, tropisetron, and ondansetron groups, respectively. After completion of the surgery, the patients were followed for 48 hours. Diclofenac sodium (100 mg IM) was administered to patients experiencing pain and metoclopramide chloride (10 mg IM) was administered to patients with nausea or vomiting. Potential side effects such as headache and constipation were recorded in the postanesthesia care unit and ear, nose, and throat clinic.
RESULTS
There was no significant difference in the effects of all 3 antiemetic agents on the severity of PONV ( = 0.081). At 48 hours postoperatively, the incidence of PONV was significantly lower in the palonosteron group (38.2%) than the ondansetron group (63.6%) and tropisetron group (61.8%) ( = 0.011). At 48 hours postoperatively, the incidence of postoperative nausea was significantly lower in the palonosetron group (32.7%) than in the ondansetron group (63.6%) and the tropisetron group (56.4%) ( = .003). The incidence of PONV between hours 12 and 24 postoperatively was significantly higher in the ondansetron group (27.3%) than in the palonosetron group (9.1%) ( = 0.013). The antiemetic requirement in the first hour after surgery was significantly higher in the tropisetron group (25.5%) than in the palonosetron group (7.3%) ( = .019).
CONCLUSIONS
The results of the current study support those of earlier studies that suggest that palonosetron was statistically more effective than the other 2 formulations in the prevention of PONV in patients who have undergone middle ear surgery. ( 2019; 80:XXXXXX).
PubMed: 31384338
DOI: 10.1016/j.curtheres.2019.06.002 -
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 -
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