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Computational and Mathematical Methods... 2022Postoperative nausea and vomiting (PONV) is a typical and unpleasant physical symptom that occurs in patients after surgery, and it may be one of the most challenging... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Postoperative nausea and vomiting (PONV) is a typical and unpleasant physical symptom that occurs in patients after surgery, and it may be one of the most challenging elements of the recovery process. PONV can be caused by a variety of factors, including surgery itself, anesthesia, or medications. Palonosetron is a medication that is now licensed by the Food and Drug Administration for the treatment of this ailment. The efficacy of palonosetron in reducing physical symptoms in patients following surgery was investigated in this meta-analysis and comprehensive review.
METHODS
Following a quick search of databases such as CENTRAL, EMBASE, CINAHL, Google Scholar, the Science quotation index's Web site, the United States clinical trial check-in, the United Kingdom clinical trial check-in, the New Zealand clinical trial check-in, and the Australia check-in, as well as outlines of major anesthesia meetings held in the previous five years, we were able to get a good start on our research. Growing adults who had surgery and were given other drugs were compared to individuals who did get palonosetron in randomized controlled trials.
RESULTS
A total of 8324 participants were recruited in 10 different clinical studies. It has been shown that palonosetron may significantly reduce the 24-hour PONV incidence and 95% confidence interval (CI) 0.41-0.86. When comparing the 6-hour and 48-hour time periods, the incidences of experiencing PONV were neither statistically different (RR: 0.82, 95% confidence interval: 0.61-1.09) or considerably different (RR: 0.60, 95% confidence interval: 0.33-1.10). Following in a similar vein, there was no significant difference between the groups in the occurrence of PONV after 48 hours (RR: 0.82, 95 percent CI: 0.59-1.14). The most often reported side effects of the medicine were headaches and dizziness, which were the most common. Regardless of the drug used, the difference in adverse reactions was not statistically significant.
CONCLUSION
When it comes to the prevention of early PONV, it has been shown that palonosetron is more effective than other medications. Palonosetron, on the other hand, has been demonstrated to be more effective than other medications in preventing vomiting after laparoscopic surgery.
Topics: Adult; Anesthesia; Antiemetics; Humans; Laparoscopy; Palonosetron; Postoperative Nausea and Vomiting
PubMed: 35387223
DOI: 10.1155/2022/7474053 -
Frontiers in Medicine 2022Postoperative nausea and vomiting (PONV) gives patients a bad experience and negates their good recovery from surgery.
Transcutaneous Electrical Acupoint Stimulation Decreases the Incidence of Postoperative Nausea and Vomiting After Laparoscopic Non-gastrointestinal Surgery: A Multi-Center Randomized Controlled Trial.
IMPORTANCE
Postoperative nausea and vomiting (PONV) gives patients a bad experience and negates their good recovery from surgery.
OBJECTIVE
This trial aims to assess the preventive effectiveness of transcutaneous electrical acupoint stimulation (TEAS) on the incidence of PONV in high-risk surgical patients.
DESIGN
The large sample size, multicenter, evaluator-blinded, and randomized controlled study was conducted between September 3, 2019 to February 6, 2021.
SETTING
The 12 hospitals were from different Chinese provinces.
PARTICIPANTS
After obtaining ethics approval and written informed consent, 1,655 patients with Apfel score ≥ 3 points were enrolled for selective laparoscopic non-gastrointestinal surgery under general anesthesia.
INTERVENTIONS
Patients were randomly allocated into the TEAS and Sham group with a 1:1 ratio. The TEAS group was stimulated on bilateral Neiguan and Zusanli acupoints after recovery from anesthesia on the surgical day and the next morning for 30 min, while the Sham group received an identical setting as TEAS but without currents delivered. Electronic patient self-reported scale was used to evaluate and record the occurrence of PONV.
MAIN OUTCOMES AND MEASURES
Primary clinical end point is the incidence of PONV which was defined as at least one incidence of nausea, retching, or vomiting after operation within postoperative 24 h.
RESULTS
Compared with the Sham treatment, the TEAS lowered the PONV incidence by 4.8% (29.4 vs. 34.2%, = 0.036) and vomiting incidence by 7.4% (10.4 vs. 17.8%, < 0.001). TEAS also lowered persistent nausea incidence and PONV scores and decreased PONV related complications and Quality of Recovery-40 scores ( < 0.05). TEAS lowered the 24 h PONV risk by 20% (OR, 0.80, 95% CI, 0.65 -0.98; = 0.032), and lowered hazard ratio by 17% (HR, 0.83, 95% CI, 0.70-0.99; = 0.035). Both TEAS and palonosetron were the independent PONV risk protective factors for 24 h PONV incidence and cumulative PONV incidence. The combination of TEAS and palonosetron was the most effective strategy to reduce the PONV incidence ( < 0.001).
CONCLUSIONS AND RELEVANCE
TEAS attenuated the PONV incidence and severity in high-risk surgical patients and may be applied clinically as a complement therapy to prevent PONV.
CLINICAL TRIAL REGISTRATION
https://clinicaltrials.gov/ct2/show/NCT04043247, identifier: NCT04043247.
PubMed: 35360742
DOI: 10.3389/fmed.2022.766244 -
Advances in Clinical and Experimental... Mar 2022Chemotherapy-induced nausea and vomiting (CINV) is a troublesome side-effect of chemotherapy in pediatric patients undergoing osteosarcoma treatment. In this context,... (Randomized Controlled Trial)
Randomized Controlled Trial
Does a single dose of palonosetron have any role in preventing acute chemotherapy-induced nausea and vomiting in pediatric osteosarcoma patients without dexamethasone? A randomized clinical trial.
BACKGROUND
Chemotherapy-induced nausea and vomiting (CINV) is a troublesome side-effect of chemotherapy in pediatric patients undergoing osteosarcoma treatment. In this context, the role of 5-hydroxytryptamine-3 (5-HT3) receptor antagonists needs to be explored.
OBJECTIVES
To evaluate the superiority of single-dose palonosetron over granisetron in pediatric patients undergoing highly emetogenic chemotherapy (HEC) for osteosarcoma.
MATERIAL AND METHODS
In this double-blind, randomized study, pediatric patients were assessed in terms of acute nausea and vomiting following HEC for osteosarcoma. These children were assigned to group 1 (palonosetron) and group 2 (granisetron) without any other antiemetic prophylaxis. The primary outcome variable was the children's segment with a complete response (CR) during the acute phase of the 1st on-study chemotherapy cycle. The risk factors associated with the emesis were analyzed. The patients were followed up for the first 24 h after chemotherapy.
RESULTS
A total number of 200 children were evaluated in terms of the response, and other factors that might alter the response were assessed in the 2 groups. These 200 children underwent 604 blocks of chemotherapy. Complete responses were documented in 83% and 72% of children receiving palonosetron and granisetron, respectively, during the acute phase. Only dexamethasone, used as a rescue medication, was found to be a significant risk factor that predisposed to the response (p < 0.05).
CONCLUSIONS
Single-dose palonosetron is an effective alternative to granisetron for preventing CINV in children receiving HEC for osteosarcoma.
Topics: Antineoplastic Agents; Child; Dexamethasone; Humans; Isoquinolines; Nausea; Osteosarcoma; Palonosetron; Quinuclidines; Vomiting
PubMed: 35302300
DOI: 10.17219/acem/142332 -
American Health & Drug Benefits Dec 2021Granisetron extended-release subcutaneous (SC) injection is a novel formulation of granisetron for the prevention of acute and delayed chemotherapy-induced nausea and...
BACKGROUND
Granisetron extended-release subcutaneous (SC) injection is a novel formulation of granisetron for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV). Palonosetron is administered intravenously and is indicated for CINV prevention in acute and delayed phases after the use of moderately emetogenic chemotherapy (MEC) and in the acute phase after highly emetogenic chemotherapy (HEC). No data are available regarding the impact of SC granisetron on the cost of unscheduled hydration compared with other antiemetic drugs, specifically the older-generation palonosetron.
OBJECTIVE
To compare the costs of unscheduled hydration associated with breakthrough CINV after SC granisetron versus palonosetron administration in patients receiving MEC or HEC.
METHODS
This retrospective analysis was based on electronic medical records data from a single multicenter, community-based practice involving patients receiving MEC or HEC with a 3-drug antiemetic regimen, including a neurokinin-1 receptor antagonist, dexamethasone, and either SC granisetron or palonosetron. A cost-of-care analysis for SC granisetron and palonosetron was based on the maximum per-unit Medicare reimbursement amounts for the use of unscheduled hydration, administration of rescue antiemetic drugs, laboratory tests, and patient office evaluations.
RESULTS
A total of 182 patient records were evaluated, 91 for patients receiving SC granisetron and 91 receiving palonosetron. The mean per-patient cost of care related to unscheduled hydration in patients receiving HEC or MEC was significantly lower with SC granisetron ($296) than palonosetron ($837; <.0001), including subset analysis of patients requiring additional care (SC granisetron [$691], N = 39; palonosetron [$1058], N = 72; = .0260). The mean hydration costs per patient receiving HEC or MEC were lower with SC granisetron ($62) than with palonosetron ($253; <.0001). The hydration costs per patient receiving only HEC were lower with SC granisetron ($66) than palonosetron ($280; <.0001). The per-patient costs were lower when SC granisetron was administered than when palonosetron was administered as part of the antiemetic regimen, except for the cost of rescue antiemetic drug in patients receiving MEC. Fewer median unscheduled hydration therapies per patient were used with SC granisetron versus palonosetron (HEC, 3 vs 5; MEC, 2 vs 3).
CONCLUSION
The use of SC granisetron reduced the total per-patient costs of care associated with unscheduled hydration compared with palonosetron in patients receiving HEC or MEC for breakthrough CINV events.
PubMed: 35261717
DOI: No ID Found -
American Health & Drug Benefits Sep 2021Granisetron extended-release subcutaneous (SC) injection is a novel formulation of granisetron for the prevention of acute and delayed chemotherapy-induced nausea and...
BACKGROUND
Granisetron extended-release subcutaneous (SC) injection is a novel formulation of granisetron for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV). Palonosetron is administered intravenously and is indicated for CINV prevention in acute and delayed phases after the use of moderately emetogenic chemotherapy (MEC) and in the acute phase after highly emetogenic chemotherapy (HEC). No data are available regarding the impact of SC granisetron on the cost of unscheduled hydration compared with other antiemetic drugs, specifically the older-generation palonosetron.
OBJECTIVE
To compare the costs of unscheduled hydration associated with breakthrough CINV after SC granisetron versus palonosetron administration in patients receiving MEC or HEC.
METHODS
This retrospective analysis was based on electronic medical records data from a single multicenter, community-based practice involving patients receiving MEC or HEC with a 3-drug antiemetic regimen, including a neurokinin-1 receptor antagonist, dexamethasone, and either SC granisetron or palonosetron. A cost-of-care analysis for SC granisetron and palonosetron was based on the maximum per-unit Medicare reimbursement amounts for the use of unscheduled hydration, administration of rescue antiemetic drugs, laboratory tests, and patient office evaluations.
RESULTS
A total of 182 patient records were evaluated, 91 for patients receiving SC granisetron and 91 receiving palonosetron. The mean per-patient cost of care related to unscheduled hydration in patients receiving HEC or MEC was significantly lower with SC granisetron ($296) than palonosetron ($837; <.0001), including subset analysis of patients requiring additional care (SC granisetron [$691], N = 39; palonosetron [$1058], N = 72; = .0260). The mean hydration costs per patient receiving HEC or MEC were lower with SC granisetron ($62) than with palonosetron ($253; <.0001). The hydration costs per patient receiving only HEC were lower with SC granisetron ($66) than palonosetron ($280; <.0001). The per-patient costs were lower when SC granisetron was administered than when palonosetron was administered as part of the antiemetic regimen, except for the cost of rescue antiemetic drug in patients receiving MEC. Fewer median unscheduled hydration therapies per patient were used with SC granisetron versus palonosetron (HEC, 3 vs 5; MEC, 2 vs 3).
CONCLUSION
The use of SC granisetron reduced the total per-patient costs of care associated with unscheduled hydration compared with palonosetron in patients receiving HEC or MEC for breakthrough CINV events.
PubMed: 35261710
DOI: No ID Found -
Oncology and Therapy Jun 2022We describe the results of an exploratory analysis performed on the first head-to-head study (JapicCTI-194611) comparing two different intravenous (IV) neurokinin 1 (NK)...
Exploratory Analysis Comparing Fosnetupitant Versus Fosaprepitant for Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting (CINV): A Randomized, Double-Blind, Phase 3 Study (CONSOLE).
INTRODUCTION
We describe the results of an exploratory analysis performed on the first head-to-head study (JapicCTI-194611) comparing two different intravenous (IV) neurokinin 1 (NK) receptor antagonists, fosnetupitant and fosaprepitant, in combination with palonosetron (PALO) and dexamethasone (DEX) for the prevention of highly emetogenic chemotherapy (HEC)-induced nausea and vomiting (CINV). This analysis was performed to validate the findings of the primary analysis (previously published) utilizing a last observation carried forward (LOCF) approach for missing values for the efficacy endpoint of complete response (no emetic event and no rescue medication), while also evaluating the time periods encompassing the 0-168-hour (h) "extended overall phase" interval.
METHODS
Patients scheduled to receive cisplatin-based chemotherapy were randomized 1:1 to fosnetupitant 235 mg or fosaprepitant 150 mg in combination with PALO 0.75 mg and DEX. Complete response rates were calculated and compared (stratified by age category and sex with a Mantel-Haenszel test) during the study's primary overall phase (0-120 h) and during additional time intervals of interest [acute (0-24 h), delayed (24-120 h), extended delayed (> 24-168 h), beyond delayed (120-168 h), and extended overall (0-168 h)].
RESULTS
A total of 785 patients were included (fosnetupitant N = 392, fosaprepitant N = 393). Complete response rates were numerically higher for fosnetupitant versus fosaprepitant for all time intervals and statistically significant for the extended overall phase. Complete response rates for fosnetupitant versus fosaprepitant during the overall, acute, delayed, extended delayed, beyond delayed, and extended overall phases were 75.5% vs. 71.0% (p = 0.1530), 93.9% vs. 92.6% (p = 0.4832), 77.0% vs. 72.8% (p = 0.1682), 74.7% vs. 68.4% (p = 0.0506), 86.7% vs. 81.7% (p = 0.0523), and 73.5% vs. 66.9% (p = 0.0450), respectively.
CONCLUSION
In this exploratory analysis, fosnetupitant appeared to be more effective than fosaprepitant in preventing CINV associated with cisplatin-based HEC during the extended 7-day period following chemotherapy. INFOGRAPHIC.
PubMed: 35246827
DOI: 10.1007/s40487-022-00188-2 -
Annals of Palliative Medicine Jan 2022Esketamine is used to control postoperative pain and reduce postoperative depression in surgical patients. This study was performed to determine the effects of...
BACKGROUND
Esketamine is used to control postoperative pain and reduce postoperative depression in surgical patients. This study was performed to determine the effects of esketamine on pain control as well as postpartum depression (PPD) in pregnant women who underwent cesarean section (CS).
METHODS
Pregnant women who underwent CS between March 2018 and February 2020 at our hospital were retrospectively reviewed. Parturients in the control group received 50 µg sufentanil citrate and 0.25 mg palonosetron hydrochloride, while those in the experimental group received additional 0.2-0.5 mg/kg esketamine. The primary outcomes included postoperative pain control according to the numeric rating scale (NRS) and the incidence of PPD according to the Edinburgh postnatal depression scale (EPDS). Multivariable linear regression analysis was performed to determine the relationship between the use of esketamine, pain control, and the incidence of PPD after CS.
RESULTS
There were 132 parturients in the control group and 108 parturients in the esketamine group in this study. All NRS scores at rest at any time point were much lower in the esketamine group than those in the control group. Besides, NRS scores when coughing were also lower in the esketamine group within 24 hours. EPDS scores were lower in the esketamine group than those in the control group within 3 months postpartum. Esketamine acted as a protector of pain control and was confirmed to improve the incidence of PPD using multivariable linear regression. Parturients had dramatically better sleep quality within 1 week postpartum (P=0.044), and morphine consumption within 24 hours postpartum was lower in the esketamine group than in the control group (P<0.001). The quality of recovery within 3 months postpartum was also better in the esketamine group (P=0.001). A subgroup analysis of 2 subgroups divided according to the dose of esketamine was then performed, indicating no significant difference between the low-dose group and high-dose group in most included outcomes.
CONCLUSIONS
This study confirmed the effects of esketamine on pain control and the incidence of PPD in pregnant women who underwent CS. Considering the potential adverse events, low-dose esketamine may be more suitable for pregnant women who have undergone CS.
Topics: Cesarean Section; Depression, Postpartum; Female; Humans; Ketamine; Pain, Postoperative; Pregnancy; Retrospective Studies
PubMed: 35144397
DOI: 10.21037/apm-21-3343 -
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 -
Cancer Apr 2022Fosnetupitant (FosNTP), an intravenous neurokinin 1 receptor antagonist, demonstrated a favorable safety profile with a potentially low risk of injection site reactions... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Fosnetupitant (FosNTP), an intravenous neurokinin 1 receptor antagonist, demonstrated a favorable safety profile with a potentially low risk of injection site reactions (ISRs) and promising antiemetic efficacy in patients receiving cisplatin-based highly emetogenic chemotherapy in a previous phase 2 study. We conducted a randomized, double-blind safety study to evaluate the safety profile of FosNTP, including ISRs, in patients receiving doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide (AC/EC) chemotherapy.
METHODS
Patients scheduled to receive AC/EC were randomized 1:1 to receive 235 mg of FosNTP or 150 mg of fosaprepitant (FosAPR), both in combination with 0.75 mg of intravenous palonosetron and 9.9 mg of dexamethasone on day 1. The stratification factors were age category (<55 vs ≥55 years) and study site. The primary end point was the incidence of treatment-related adverse events (TRAEs) with FosNTP.
RESULTS
Overall, 102 patients were randomized to FosNTP (n = 52) or FosAPR (n = 50), and all were treated with the study drug and evaluated for safety. The primary end point, the incidence of TRAEs, was similar with FosNTP (21.2%; 95% confidence interval [CI], 11.1%-34.7%) and FosAPR (22.0%; 95% CI, 11.5%-36.0%), with any-cause ISRs observed in 5.8% and 26.0% of patients, respectively, and treatment-related ISRs observed in 0% and 10.0%, respectively. The overall (0-120 hour) complete response (defined as no emetic event and no rescue medication) rate, standardized by age category in the full analysis set, was 45.9% (23 of 51 patients) with FosNTP and 51.3% (25 of 49 patients) with FosAPR.
CONCLUSIONS
FosNTP demonstrated a favorable safety profile with a very low risk of ISRs in the AC/EC setting.
Topics: Anthracyclines; Antiemetics; Cyclophosphamide; Dexamethasone; Double-Blind Method; Humans; Middle Aged; Nausea; Vomiting
PubMed: 35045185
DOI: 10.1002/cncr.34088 -
Perioperative Medicine (London, England) Dec 2021Delirium is an important postoperative complication. Recent research suggested that 5-hydroxytryptamine 3 (5-HT) receptor antagonists may have clinical effect in the...
BACKGROUND
Delirium is an important postoperative complication. Recent research suggested that 5-hydroxytryptamine 3 (5-HT) receptor antagonists may have clinical effect in the treatment and prevention of delirium. We investigated the association between 5-HT receptor antagonists and the occurrence of postoperative delirium (POD).
METHODS
Retrospectively, the electronic medical records were reviewed in patients aged ≥ 65 years who underwent orthopedic lower limb surgery under regional anesthesia (spinal or combined spinal-epidural anesthesia) and administered intravenous 0.075 mg palonosetron or 0.3 mg ramosetron prior to the end of surgery between July 2012 and September 2015. POD incidence and anesthesia-, surgery-, and patient-related factors were evaluated. To investigate the association between 5-HT receptor antagonists and the occurrence of POD, multivariable logistic regression analysis was performed.
RESULTS
Of the 855 patients included, 710 (83%) were administered 5-HT receptor antagonists. POD was confirmed in 46 (5.4%) patients. 5-HT receptor antagonists reduced the POD incidence by 63% (odds ratio [OR] 0.37; 95% confidence interval [CI], 0.15-0.94; P = 0.04). Moreover, the POD incidence decreased by 72% (OR 0.28, 95% CI 0.10-0.77, P = 0.01) when palonosetron was administered. Other identified risk factors for POD were emergency surgery, older age, hip surgery, lower body mass index, and intraoperative propofol sedation.
CONCLUSION
5-HT receptor antagonists may be related with a significantly reduced risk for POD in older patients undergoing orthopedic lower limb surgery. Notably, palonosetron was more effective for POD prevention.
PubMed: 34876219
DOI: 10.1186/s13741-021-00222-3