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A prospective, randomized, double-blind trial to compare body weight-adjusted and fixed doses of palonosetron for preventing postoperative nausea and vomiting in obese female patients.

ABSTRACT: BACKGROUND:Postoperative nausea and vomiting (PONV) is a common postsurgical complication. Palonosetron is effective for PONV prevention at the usual dose of 75 ?g, but the ideal dose for obese patients has not yet been investigated. The aim of this study was to compare body weight-adjusted and fixed doses of palonosetron for preventing PONV in obese female patients. MATERIALS AND METHODS:We performed a prospective, randomized, double-blind trial involving 80 female patients, aged 18-80 years with an American Society of Anesthesiologists physical status of 2 and 3 and a body mass index (BMI) ? 30 kg m-2 who were scheduled to undergo elective breast surgery. Patients received an intravenous body weight-adjusted dose of palonosetron (1 ?g kg -1, GI = 40 patients) or a fixed dose of palonosetron (75 ?g, GII = 40 patients). All patients received dexamethasone (4 mg). The incidence of PONV, complete response rate (CR), severity of nausea and need for rescue antiemetics and analgesics were assessed at: 0-1 h, 1-6 h, 6-24 h and 24-48 h postoperatively. RESULTS:The mean (± SD) BMI was 35.0 (±5.2) kg m-2 for GI and 35.7 (±3.6) kg m-2 for GII. There was no significant difference between groups in PONV incidence, CR, severity of nausea, and need for rescue antiemetics or analgesics. The incidence of PONV for GI and GII was 15% and 27.5%, respectively, during the first 48 h (P = 0.17). CONCLUSIONS:A body weight-adjusted dose of palonosetron was as effective as 75 ?g for preventing PONV for 48 h in obese female patients who underwent breast surgery. Hence, the fixed dose may be preferable to the body weight-adjusted dose.

SUBMITTER: Gouveia de Araujo Ferreira N

PROVIDER: S-EPMC6959980 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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A prospective, randomized, double-blind trial to compare body weight-adjusted and fixed doses of palonosetron for preventing postoperative nausea and vomiting in obese female patients.

Gouveia de Araujo Ferreira Nathalia N Cavalcanti Ismar Lima IL Assad Alexandra Rezende AR Barrucand Louis L Braga Estêvão Luiz Carvalho ELC Verçosa Nubia N

PloS one 20200114 1

<h4>Background</h4>Postoperative nausea and vomiting (PONV) is a common postsurgical complication. Palonosetron is effective for PONV prevention at the usual dose of 75 μg, but the ideal dose for obese patients has not yet been investigated. The aim of this study was to compare body weight-adjusted and fixed doses of palonosetron for preventing PONV in obese female patients.<h4>Materials and methods</h4>We performed a prospective, randomized, double-blind trial involving 80 female patients, aged ...[more]

PMID: 31935249

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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:BackgroundPostoperative nausea and vomiting (PONV) are common complications following surgery and anaesthesia. Drugs to prevent PONV are only partially effective. An alternative approach is to stimulate the P6 acupoint on the wrist. This is an update of a Cochrane review first published in 2004.ObjectivesTo determine the efficacy and safety of P6 acupoint stimulation in preventing PONV.Search strategyWe searched CENTRAL (The Cochrane Library, Issue 3, 2008), MEDLINE (January 1966 to September 2008), EMBASE (January 1988 to September 2008), ISI Web of Science (January 1965 to September 2008), the National Library of Medicine publication list of acupuncture studies, and reference lists of articles.Selection criteriaAll randomized trials of techniques that stimulated the P6 acupoint compared with sham treatment or drug therapy for the prevention of PONV. Interventions used in these trials included acupuncture, electro-acupuncture, transcutaneous nerve stimulation, laser stimulation, capsicum plaster, an acu-stimulation device, and acupressure in patients undergoing surgery. Primary outcomes were the risks of nausea and vomiting. Secondary outcomes were the need for rescue antiemetic therapy and adverse effects.Data collection and analysisTwo review authors independently assessed trial quality and extracted the data. We collected adverse effect information from the trials. We used a random-effects model and reported relative risk (RR) with associated 95% confidence intervals (95% CI).Main resultsWe included 40 trials involving 4858 participants; four trials reported adequate allocation concealment. Twelve trials did not report all outcomes. Compared with sham treatment P6 acupoint stimulation significantly reduced: nausea (RR 0.71, 95% CI 0.61 to 0.83); vomiting (RR 0.70, 95% CI 0.59 to 0.83), and the need for rescue antiemetics (RR 0.69, 95% CI 0.57 to 0.83). Heterogeneity among trials was moderate. There was no clear difference in the effectiveness of P6 acupoint stimulation for adults and children; or for invasive and noninvasive acupoint stimulation. There was no evidence of difference between P6 acupoint stimulation and antiemetic drugs in the risk of nausea (RR 0.82, 95% CI 0.60 to 1.13), vomiting (RR 1.01, 95% CI 0.77 to 1.31), or the need for rescue antiemetics (RR 0.82, 95% CI 0.59 to 1.13). The side effects associated with P6 acupoint stimulation were minor. There was no evidence of publication bias from contour-enhanced funnel plots.Authors' conclusionsP6 acupoint stimulation prevented PONV. There was no reliable evidence for differences in risks of postoperative nausea or vomiting after P6 acupoint stimulation compared to antiemetic drugs.

Project description:BackgroundDespite 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.MethodsThis 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.FindingsBetween 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%; P = 0.0010; rate difference, RD 15%, 95% CI, 6% to 23%) and in the delayed phase (25-120 h), 90.6% vs. 75.5%, (P < 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%, (P = 0.94; RD 0%, 95% CI, -5% to 6%)). In the overall phase, the incidence of insomnia (P < 0.0010), dyspepsia (P = 0.038), and flushing (P = 0.0010) reported by the patients was significantly higher in the dexamethasone group than that in the aprepitant group.InterpretationAprepitant combined with palonosetron is superior to dexamethasone combined with palonosetron in patients who received the MEC regimen mFOLFOX6 in terms of preventing CINV.FundingThe National Key R&D Program of China (2019YFC1316000) and the National Natural Science Foundation of China (81974369).

Dataset Information

A prospective, randomized, double-blind trial to compare body weight-adjusted and fixed doses of palonosetron for preventing postoperative nausea and vomiting in obese female patients.

Publications

A prospective, randomized, double-blind trial to compare body weight-adjusted and fixed doses of palonosetron for preventing postoperative nausea and vomiting in obese female patients.

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