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临床试验/NCT04868747
NCT04868747撤回不适用

The Effect of Perioperative Lidocaine Intravenous Infusion on Neutrophil Extracellular Trapping After Surgery for Stomach Cancer

The Catholic University of Korea1 个研究点 分布在 1 个国家开始时间: 2021年4月1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
撤回
试验地点
1
主要终点
serum concentration of NET(neutrophil extracellular trapping)-related biomarker

研究概览

简要总结

To investigate the effect of perioperative lidocaine infusion on the neutrophil extracellular trapping after minimally invasive surgery for stomach cancer

详细描述

To investigate the effect of perioperative lidocaine infusion on the neutrophil extracellular trapping, especially citrullinated histone3, neutrophil elastase, myeloperoxidase

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of stomach cancer
  • ASA class I-III
  • no metastatic disease

排除标准

  • hepatic, renal disease
  • chronic inflammatory disease, eg. rheumatoid arthritis
  • steroid or anti-inflammatory drug medication
  • allergies to study drugs
  • neuropsychiatric disease
  • refusal of participation
  • breast feeding or pregnancy
  • weight < 40 kg

研究组 & 干预措施

study group

Experimental

The study group receives the intravenous 1% lidocaine 1.5 mg/kg bolus followed by 1.5 mg/kg/h during surgery and 1.0 mg/kg/h until 24 hours after surgery (Max.<120 mg/h).

干预措施: Lidocaine (Drug)

control group

Placebo Comparator

The control group receives intravenous normal saline 0.15 ml/kg bolus followed by 0.15 ml/kg/h during surgery and 0.1 mg/kg/h until 24 hours after surgery.

干预措施: normal saline (Drug)

结局指标

主要结局

serum concentration of NET(neutrophil extracellular trapping)-related biomarker

时间窗: 24 hours after surgery

NET-related biomarker (citrullinated histone3, neutrophil elastase, myeloperoxidase)

次要结局

  • survival of patients(5 years)
  • quality of recovery(24 hours after surgery)
  • postoperative pain(24 hours after surgery)

研究者

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

Young Eun Moon

Associate professor

The Catholic University of Korea

研究点 (1)

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