跳至主要内容
临床试验/NCT02827682
NCT02827682Unknown不适用

The Effect of IoC on the Level of Intraoperative Analgesia for Elderly Patients With Postoperative Effectiveness

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Duration time in PACU

研究概览

简要总结

The morbidity of colorectal cancer and the surgery number among elderly is growing. The investigators need to provide more advanced and specific monitoring technology for these patients. Index of consciousness (IoC) monitor is now widely used among endoscopy, cholecystectomy and other common clinical applications. The investigators goal is to verify whether using IoC monitor could help to improve the postoperative recovery after colorectal surgery.

详细描述

Participants will be randomly assigned, in a 1:1 ratio, to receive IoC monitoring or BIS monitoring during the operation as the criteria for adjustment of analgesics use. The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. The number of dialysis and patient's recovery after the transplantation will be recorded. The participation of each patient is scheduled till they discharge from hospital.

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • Patients aged over 60 years old that underwent Colorectal surgery in the First Affiliated Hospital of Xi'an Jiaotong University.

排除标准

  • Having severe comorbidity history,for example,severe cardiac dysfunction
  • Having central nervous system disease, severe endocrine, and history of mental disorders
  • Alcoholic and long-term use of sedatives and opioids history
  • Drug allergy history.

结局指标

主要结局

Duration time in PACU

时间窗: 24 hours

patients able to leave PACU with the proper Aldrete score

次要结局

  • Use of remifentanil(during surgery)
  • Use of propofol(during surgery)
  • length of hospital stay (LOS)(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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