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临床试验/NCT04325984
NCT04325984已完成不适用

Ruolo Del Desametasone Per il Controllo Multimodale Del Dolore Postoperatorio in Chirurgia Toracica

University of Trieste1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2017年8月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
Morphine consumption

研究概览

简要总结

The aim of the study is to evaluate the analgesic properties of dexamethasone and to quantify the possible associated postoperative complications, such as wound infections and hyperglycaemia, in patients who underwent lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or video-assisted thoracoscopic surgery (VATS).

详细描述

We designed an observational study, aimed to evaluate the possible reduction in morphine consumption in thoracic patients, who were administered dexamethasone compared to who didn't received the drug.

The research wants to assess the presence of additional analgesic properties, besides the well known antiemetic effect, in the intraoperative administration of dexamethasone, and the possible postoperative complications, such as wound infections and hyperglycaemia.

The rational is to ameliorate the anaesthesiological management, in particular with a view to a opioid-sparing analgesia in thoracic patients.

To do so, we enrolled thoracic patients, who underwent elective lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or video-assisted thoracoscopic surgery (VATS).

We selected two groups: one in which patients were administered dexamethasone 8 mg at the moment of induction, and the other one in which patients didn't received dexamethasone, but ondansetron 4 mg at the end of surgery. Both groups received other antiemetic drugs based on Apfel score and multimodal analgesia, comprising loco-regional analgesia, opioids and other analgesic drugs administration.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI < 30 kg/m2
  • ASA I-III
  • Lobectomy, segmentectomy or atypical resection surgery with a mini-thoracotomy approach or VATS

排除标准

  • Refusal by the patient to participate or patient unable to express his own consent
  • Chronic therapy with medium-high doses of corticosteroids
  • Chronic therapy with opioids
  • METS ≤ 4, defining an overall decreased cardiovascular fitness
  • Urgent or emergency surgery
  • Allergy to the active ingredient of the drug used
  • Kidney failure at stage III or more
  • Liver failure
  • Pregnancy
  • Drug addiction, patients with a history of drug abuse
  • Corrected Qt interval (QTc) > 0,45 for males and 0,47 for women

研究组 & 干预措施

Dexamethasone group

Group of patients receiving dexamethasone 8 mg as part of the multimodal analgesia.

干预措施: Dexamethasone (Drug)

结局指标

主要结局

Morphine consumption

时间窗: 24 hours after surgery

Morphine dose, in milligrams, administered in the 24 hours after the surgery

次要结局

  • Static and dynamic Numeric Rating Scale (NRS)(24 hours after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marzia Umari

Principal Investigator

University of Trieste

研究点 (1)

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