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临床试验/NCT03271606
NCT03271606Unknown1 期

The Clinical Study of ERAS Protocol in Video-assisted Mediastinal Surgery

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年8月23日最近更新:
适应症
干预措施

试验速览

阶段
1 期
发起方
入组人数
100
试验地点
1
主要终点
15-item quality of recovery scale (QoR-15)

研究概览

简要总结

This is a single center, randomized,single blind study to investigate the effectiveness of enhanced recovery regimen (ERAS) in patients undergoing Video-assisted Mediastinal Surgery. And we also going to compare the effectiveness of ERAS with that of traditional regimen in these patients.

详细描述

Compare to traditional measures, the ERAS protocal mainly includes:Good preoperative visit, shorten the fast time, minimumal invasive surgery procedures, fewer opioids and early movements after surgery. These items have been successfully used in colon cancer surgery, and we thus plan to investigate the effectiveness of these measures in mediastinal surgery.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients elective mediastinal surgery;
  • BMI 18-30 kg/m2.

排除标准

  • Patient refuse;
  • Patients allergic to used anesthetics (propofol,rocuronium), patients with liver and/or kidney and/or mental dysfunction.

研究组 & 干预措施

ERAS group

Experimental

The patients in this group receive enhanced measures perioperatively

干预措施: ERAS (Combination Product)

Traditional group

Active Comparator

The patients in this group receive traditional measures perioperatively

干预措施: Traditional measures (Combination Product)

结局指标

主要结局

15-item quality of recovery scale (QoR-15)

时间窗: At 24 hours after surgery

This scale mainly reflects the patient's status

次要结局

未报告次要终点

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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ERAS in Video-assisted Mediastinal Surgery | 临床试验