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Effects of palonosetron for prophylaxis of postoperative nausea and vomiting in high-risk patients undergoing total knee arthroplasty: A prospective, randomized, double-blind, placebo-controlled study.

ABSTRACT: The preemptive multimodal pain protocols used in total knee arthroplasty (TKA) often cause emesis postoperatively. We investigated whether palonosetron prophylaxis reduces postoperative nausea and vomiting (PONV) in high-risk patients after TKA.We randomized 120 female patients undergoing TKA to receive either palonosetron (0.075 mg, intravenous) or no antiemetic prophylaxis (0.9% saline, control group). All patients were given spinal anesthesia, a continuous femoral nerve block, and fentanyl-based intravenous patient controlled analgesia. Patients undergoing staged bilateral TKA were assigned to one group for the first knee and the other group for the second knee. The overall incidence of PONV, the incidences of both nausea and vomiting, severity of nausea, complete response, requirement for rescue antiemetics, pain level, opioid consumption, and satisfaction scores were evaluated during three periods: 0-2, 2-24, and 24-48 h postoperatively. We also compared PONV and pain between the first and second TKA.The incidence of PONV during the first 48 h was lower in the palonosetron group compared with the controls (22 vs. 41%, p = 0.028), especially 2-24 h after surgery, as was the nausea and vomiting respectively. The severity of nausea was lower in the palonosetron group (p = 0.010). The complete response rate (93 vs. 73%, p = 0.016) and satisfaction score (84 ± 12 vs. 79 ± 15, p = 0.032) were higher in the palonosetron group during 2-24 h after surgery. Patients who underwent a second operation complained of more severe pain, and consumed more opioids than those of the first operation. There was no difference in the incidence of PONV between the first and second operations.Palonosetron prophylaxis reduced the incidence and severity of PONV in high-risk patients managed with multimodal pain protocol for 48 h, notably 2-24 h after TKA.

SUBMITTER: Ryu JH

PROVIDER: S-EPMC5951557 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Effects of palonosetron for prophylaxis of postoperative nausea and vomiting in high-risk patients undergoing total knee arthroplasty: A prospective, randomized, double-blind, placebo-controlled study.

Ryu Jung-Hee JH Jeon Young-Tae YT Min Byunghun B Hwang Jin-Young JY Sohn Hye-Min HM

PloS one 20180514 5

<h4>Background</h4>The preemptive multimodal pain protocols used in total knee arthroplasty (TKA) often cause emesis postoperatively. We investigated whether palonosetron prophylaxis reduces postoperative nausea and vomiting (PONV) in high-risk patients after TKA.<h4>Methods</h4>We randomized 120 female patients undergoing TKA to receive either palonosetron (0.075 mg, intravenous) or no antiemetic prophylaxis (0.9% saline, control group). All patients were given spinal anesthesia, a continuous f ...[more]

PMID: 29758039

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Project description:BackgroundThis 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.MethodsThis 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.ResultsOf 239 patients screened, 220 were enrolled and 98 were treated for PONV: 48 and 50 in the palonosetron and ondansetron arms, respectively. Complete control during 72 hours after study drug administration was achieved in 25.0% of palonosetron recipients and 18.0% of ondansetron recipients (95% confidence interval [CI], -9.2, 23.3; p = 0.40). Corresponding incidences of vomiting were 29.2% for palonosetron and 48.0% for ondansetron (95% CI, -0.06, 37.7; p = 0.057), and 62.5% and 56.0% required additional rescue treatment, respectively (95% CI, -25.9, 12.9; p = 0.52). Other than a similar incidence of procedural pain in the 2 groups, the most common treatment-emergent adverse events, which were generally mild, were headache (14.6% vs 12.0%), constipation (8.3% vs 10.0%), and dizziness (6.3% vs 8.0%), for the palonosetron and ondansetron groups, respectively.ConclusionsPalonosetron and ondansetron did not show differences in the primary efficacy endpoint of CC during the 72 hours after study drug administration. There was a trend toward less emesis in the 0-72 h time period favoring palonosetron. While larger studies are needed to fully assess any clinical benefits of palonosetron to rescue patients who have failed ondansetron prophylaxis for PONV, the benefit, if any, would be limited based on this study.Trial registrationClinicalTrials.gov, NCT00967499 (Registered August 27, 2009).

Project description:INTRODUCTION:Postoperative nausea and vomiting (PONV) is a displeasing experience that distresses surgical patients during the first 24?h after a surgical procedure. The incidence of postoperative nausea occurs in about 50%, the incidence of postoperative vomiting is about 30%, and in high-risk patients, the PONV rate could be as high as 80%. Therefore, the study design of this single arm, non-randomized, pilot study assessed the efficacy and safety profile of a triple therapy combination with palonosetron, dexamethasone, and promethazine to prevent PONV in patients undergoing craniotomies under general anesthesia. METHODS:The research protocol was approved by the institutional review board and 40 subjects were provided written informed consent. At induction of anesthesia, a triple therapy of palonosetron 0.075?mg IV, dexamethasone 10?mg IV, and promethazine 25?mg IV was given as PONV prophylaxis. After surgery, subjects were transferred to the surgical intensive care unit or post anesthesia care unit as clinically indicated. Ondansetron 4?mg IV was administered as primary rescue medication to subjects with PONV symptoms. PONV was assessed and collected every 24?h for 5?days via direct interview and/or medical charts review. RESULTS:The overall incidence of PONV during the first 24?h after surgery was 30% (n?=?12). The incidence of nausea and emesis 24?h after surgery was 30% (n?=?12) and 7.5% (n?=?3), respectively. The mean time to first emetic episode, first rescue, and first significant nausea was 31.3 (±33.6), 15.1 (±25.8), and 21.1 (±25.4) hours, respectively. The overall incidence of nausea and vomiting after 24-120?h period after surgery was 30% (n?=?12). The percentage of subjects without emesis episodes over 24-120?h postoperatively was 70% (n?=?28). No subjects presented a prolonged QTc interval ?500?ms before and/or after surgery. CONCLUSION:Our data demonstrated that this triple therapy regimen may be an adequate alternative regimen for the treatment of PONV in patients undergoing neurological surgery under general anesthesia. More studies with a control group should be performed to demonstrate the efficacy of this regimen and that palonosetron is a low risk for QTc prolongation. CLINICALTRIALSGOV IDENTIFIER:NCT02635828 (https://clinicaltrials.gov/show/NCT02635828).

Dataset Information

Effects of palonosetron for prophylaxis of postoperative nausea and vomiting in high-risk patients undergoing total knee arthroplasty: A prospective, randomized, double-blind, placebo-controlled study.

Publications

Effects of palonosetron for prophylaxis of postoperative nausea and vomiting in high-risk patients undergoing total knee arthroplasty: A prospective, randomized, double-blind, placebo-controlled study.

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