Evidence map›Paper›PMID 31935249›Full record

Trial reportPloS one2020

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.

Nathalia Gouveia de Araujo Ferreira, Ismar Lima Cavalcanti, Alexandra Rezende Assad, Louis Barrucand, Estêvão Luiz Carvalho Braga, Nubia Verçosa

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04853147 (Triple Combination of Fosaprepitant, Dexamethasone and Palonosetron Versus Combination of Dexamethasone and Palonosetron for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastrointestinal Surgery), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04853147 phase3completednot on this mapstarted 2021, after this paper: background citation

Triple Combination of Fosaprepitant, Dexamethasone and Palonosetron Versus Combination of Dexamethasone and Palonosetron for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastrointestinal Surgery

TypeinterventionalSponsorSixth Affiliated Hospital, Sun Yat-sen UniversityRan2021 to 2022Enrolled1,154ConditionsC.Surgical Procedure, GastrointestinalArmspalonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl, palonosetron, dexamethasone, and 0.9% NaCl
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. A study on the effect of clinical intervention of evidence-based nursing measures on complications in patients after breast-conserving surgery.Technology and health care : official journal of the European Society for Engineering and Medicine · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Nathalia Gouveia de Araujo FerreiraDepartment of Anesthesiology, National Cancer Institute (HCIII), Rio de Janeiro, Rio de Janeiro, Brazil.ORCID 0000-0002-4397-6041
Ismar Lima CavalcantiDepartment of General and Specialized Surgery/Anesthesiology, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.ORCID 0000-0002-0412-2609
Alexandra Rezende AssadDepartment of General and Specialized Surgery/Anesthesiology, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.
Louis BarrucandFaculty of Medicine, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.ORCID 0000-0003-3646-0706
Estêvão Luiz Carvalho BragaFaculty of Medicine, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.ORCID 0000-0003-3021-7369
Nubia VerçosaDepartment of Surgery/Anesthesiology, Postgraduate Program Surgical Sciences, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
Universidade Federal do Rio de Janeiro · BRUniversidade Federal Fluminense · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPostoperative 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. MATERIALS AND

methodsWe 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 μg kg -1, GI = 40 patients) or a fixed dose of palonosetron (75 μg, 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.

resultsThe 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).

conclusionsA body weight-adjusted dose of palonosetron was as effective as 75 μg 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.

Indexed as

AdolescentAdultAgedAged, 80 and overAntiemeticsBody Mass IndexBody WeightBreastDexamethasoneDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMiddle AgedObesityPalonosetronAntiemeticsDexamethasonePalonosetron

Identifiers

PMID31935249
PMCPMC6959980
OpenAlexW2999687384

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.