跳至主要内容
临床试验/NCT04183296
NCT04183296已完成不适用

The Effect of Total Intravenous Anesthesia and Volatile Anesthesia on Shedding of the Endothelial Glycocalyx in Patients Undergoing Laparoscopic or Robotic Assisted Gastrectomy

Yonsei University1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2019年11月28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
136
试验地点
1
主要终点
Changes in blood concentration of syndecan-1

研究概览

简要总结

The aim of this study was to investigate the effects of total intravenous and inhalation anesthesia on the damage of endothelial glucocorticoids by comparing the concentration of syndecan-1 before and after laparoscopic or robotic assisted gastrectomy.

详细描述

A commercial TIVA(Total Intravenous Anesthesia and Volatile Anesthesia ) pump was used for target-controlled infusion (TCI) of remifentanil and propofol. In the volatile group, anesthesia was induced with an intravenous bolus of propofol 1.5-2 mg/kg and TCI of remifentanil (effect-site concentration [Ce] of 4.0 ng/ml). In the TIVA group, anesthesia was induced with TCI of propofol (Ce of 4.0-4.5 μg/ml) and remifentanil (Ce of 4.0 ng/ml). In the volatile group, anesthesia was maintained with sevoflurane (0.8-1 age-adjusted minimum alveolar concentration [MAC]) and TCI of remifentanil, while in the TIVA group, anesthesia was maintained with TCI of propofol and remifentanil. Anesthesia depth was adjusted to maintain a PSI(Patient State Index) of 25-50. Endotracheal intubation was performed after administration of intravenous rocuronium 1.2 mg/kg and neuromuscular blockade depth was maintained to a target of train-of-four of 0-2 with infusion of rocuronium during pneumoperitoneum.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

triple (Participant, Care Provider, investigator)

入排标准

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

入选标准

  • Adult patients over 20 years old with ASA class I-III
  • Scheduled laparoscopic or robotic assisted laparoscopic gastrectomy

排除标准

  • emergency surgery
  • patients unable to make their own decisions, illiterate, foreigners
  • Allergy / hypersensitivity to sevoflurane or propofol 4, Current or past history or thrombosis / thromboembolism
  • patients who are taking oral contraceptives
  • Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less)
  • Patients receiving anticoagulants
  • pregnant and lactating women
  • Patients with history of psychiatric disease or neurological disease

研究组 & 干预措施

TIVA(Total Intravenous Anesthesia and Volatile Anesthesia )

Experimental

In the TIVA group, anesthesia was induced with TCI of propofol (Ce of 4.0-4.5 μg/ml) and remifentanil (Ce of 4.0 ng/ml). Anesthesia was maintained with TCI of propofol and remifentanil. Anesthesia depth was adjusted to maintain a PSI of 25-50.

干预措施: propofol (Drug)

Inhalation

Active Comparator

Arm Description: In the volatile group, anesthesia was induced with an intravenous bolus of propofol 1.5-2 mg/kg and TCI of remifentanil (effect-site concentration [Ce] of 4.0 ng/ml). Anesthesia was maintained with sevoflurane (0.8-1 age-adjusted minimum alveolar concentration) and TCI of remifentanil

干预措施: sevoflurane (Drug)

结局指标

主要结局

Changes in blood concentration of syndecan-1

时间窗: 1 day after surgery

Blood levels of syndecan-1 are assessed 1 day after surgery.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验