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临床试验/NCT04950205
NCT04950205Unknown早期 1 期

The Influence of Postoperative Cognitive Function in Patients With Sevoflurane Postconditioning on Carotid Intima Stripped

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
发起方
入组人数
140
试验地点
1
主要终点
Change from the 1 day preoperative to the 1 day postoperative MoCA(Montreal Cognitive Assessment)

研究概览

简要总结

Brief summary: In order to get a better clinical plan for brain protection during perioperative anesthesia for high-risk patients - carotid intima stripped. We observing the hemodynamic changes of sevoflurane post-treatment in carotid intima stripped, the comparison of postoperative cognitive function and postoperative radiographic changes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Single (Participant)

入排标准

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

入选标准

  • American Society of Anesthesiologists(ASA):II-III
  • Aged between 40 and 80 years
  • Patients scheduled for surgery of Carotid stenosis under general anaesthesia

排除标准

  • Has a history of mental illness can't cooperate,
  • Serious heart block or cardiac decompensation or severe sinus slow (HR < 50 times/min),
  • The abnormal nerve monitoring in operation, MMES preoperative score < 20 points,
  • Any rescue unexpected occurred during the operation

研究组 & 干预措施

Sevoflurane post conditioning group(S1)

Experimental

propofol:0.05~0.1mg/(kg.min) maintain throughout the whole surgery ,1% sevoflurane plus after open Carotid artery until the end of surgery

干预措施: Sevoflurane inhalant product (Drug)

结局指标

主要结局

Change from the 1 day preoperative to the 1 day postoperative MoCA(Montreal Cognitive Assessment)

时间窗: Time Frame: the 1st day before the surgery;the 1st day after the surgery

Screening scale of cognitive function。The highest score is 30 points,Add 1 score, education the following subjects in less than 12 years。Total score less than 26 divided into cognitive dysfunction。Compared with MMSE, more sensitive to mild dementia。

Change from the 1 day preoperative to the 1 day postoperative MMSE(Mini-mental State Examination)

时间窗: the 1st day before the surgery;the 1st day after the surgery

Screening scale of cognitive function。The highest score is 30 points, 27 to 30 were divided into normal, less than 27 divided into cognitive dysfunction。But is not sensitive in the early identification of dementia, especially in mild cognitive impairment is poorer.

次要结局

  • Cerebral oxygen saturation(Ten minutes before induction(T0) ,Intraoperative (Before the carotid artery occlusion(T1)), Intraoperative (before open the Carotid artery(T2),At the end of the surgery when the surgeon completed sewing skin(T3),the 24 hours after the operation(T4))
  • PETCO2(Ten minutes before induction(T0) ,Intraoperative (Before the carotid artery occlusion(T1)), Intraoperative (before open the Carotid artery(T2),At the end of the surgery when the surgeon completed sewing skin(T3),the 24 hours after the operation(T4))
  • Invasive arterial blood pressure(Ten minutes before induction(T0) ,Intraoperative (Before the carotid artery occlusion(T1)), Intraoperative (before open the Carotid artery(T2),At the end of the surgery when the surgeon completed sewing skin(T3),the 24 hours after the operation(T4))
  • BIS(Ten minutes before induction(T0) ,Intraoperative (Before the carotid artery occlusion(T1)), Intraoperative (before open the Carotid artery(T2),At the end of the surgery when the surgeon completed sewing skin(T3),the 24 hours after the operation(T4))
  • Heart rate(Ten minutes before induction(T0) ,Intraoperative (Before the carotid artery occlusion(T1)), Intraoperative (before open the Carotid artery(T2),At the end of the surgery when the surgeon completed sewing skin(T3),the 24 hours after the operation(T4))

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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