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SPI-guided Analgesia During CEA Under RA (CEA)

2020年7月31日 更新者：Michał Stasiowski、Medical University of Silesia

SPI-guided Analgesia in Patients Undergoing Carotid Endarterectomy Under Cervical Plexus Block

The aim of this randomized prospective trial is to assess the utility of Adequacy of Anaesthesia technique (Response Entropy and Surgical Pleth Index) for monitoring pain perception intraoperatively, maintainance of hemodynamic stability during anesthesia and its influence on postoperative outcomes, in patients undergoing carotid endarterectomy under cervical plexus block.

研究概览

地位

未知

条件

干预/治疗

详细说明

Carotid artery stenosis constitutes a major risk factor for ischemic stroke so carotid endarterectomy is performed to protects patients with severe atherosclerotic carotid artery stenosis against stroke.

Surgical Pleth Index (SPI) is reported to properly reflect nociception-antinociception balance in patients undergoing surgical procedures, where a value of 100 corresponds to a high stress level and a value of 0 to a low stress level; values near 50 or increase in value > delta 10 correspond to the stress level which is known to reflect requirement for rescue analgesia.

A randomized interventional trial to evaluate the effects of SPI-guided rescue analgesia on hemodynamic stability during anesthesia in patients undergoing carotid endarterectomy under cervical plexus block.

研究类型

介入性

注册 (预期的)

105

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 波兰
    • Silesia
      • Sosnowiec、Silesia、波兰、41-200
        • 招聘中
        • Medical University of Silesia
        • 接触：
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

clinical diagnosis of stenosis of carotid artery written consent to participate in the study written consent to undergo carotid endarterectomy under regional anaesthesia of cervical plexus using Moore's technique general heath condition I-III of American Society of Anaesthesiology

Exclusion Criteria:

  • necessity of administration of vasoactive drugs influencing SPI monitoring pregnancy
  • anatomical malformation that make monitoring using SE sensor impossible
  • general atherosclerosis and heart rhythm disturbances impairing SPI monitoring
  • chronic medication using opioid drugs leading to resistancy to opioids.
  • farmacotherapy with anticoagulants
  • allergy to local anaesthetics

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：CPB
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique
药品：infiltration rescue intraoperative analgesia
in the case of intraoperative pain perception, rescue infiltration analgesia using 1 % lidocaine administered by the operator into the operation field.
其他名称：
  • rescue LA
药品：rescue IA
in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist
药品：rescue antyhypertensive medication
in the case of intraoperative hypertension reluctant to rescue analgesia, rescue intravenous antihypertensive medication using 10 mcg of urapidil will be administered by anaesthesiologist
药品：rescue antyemetic medication
in the case of postoperative nausea and vomitting, rescue intravenous antiemetic medication using 4 mg of ondansetron will be administered by anaesthesiologist
药品：rescue antyhypotensive medication
in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist
药品：rescue antyhypotensive medication
in the case of intraoperative bradycardia, rescue intravenous antihypotensive medication using 500 mcg of atropine will be administered by anaesthesiologist
实验性的：CPB with SPI guided analgesia
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique alongside with SPI-guided rescue analgesia using 1% lidokaine and intravenous fentanyl
药品：infiltration rescue intraoperative analgesia
in the case of intraoperative pain perception, rescue infiltration analgesia using 1 % lidocaine administered by the operator into the operation field.
其他名称：
  • rescue LA
药品：rescue IA
in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist
药品：rescue antyhypertensive medication
in the case of intraoperative hypertension reluctant to rescue analgesia, rescue intravenous antihypertensive medication using 10 mcg of urapidil will be administered by anaesthesiologist
药品：rescue antyemetic medication
in the case of postoperative nausea and vomitting, rescue intravenous antiemetic medication using 4 mg of ondansetron will be administered by anaesthesiologist
药品：rescue antyhypotensive medication
in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist
药品：rescue antyhypotensive medication
in the case of intraoperative bradycardia, rescue intravenous antihypotensive medication using 500 mcg of atropine will be administered by anaesthesiologist
实验性的：CPB plus SPI guided analgesia plus carotid artery block
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique combined ith US-guided carotid artery block alongside with SPI-guided rescue analgesia using 1% lidokaine and intravenous fentanyl
药品：infiltration rescue intraoperative analgesia
in the case of intraoperative pain perception, rescue infiltration analgesia using 1 % lidocaine administered by the operator into the operation field.
其他名称：
  • rescue LA
药品：rescue IA
in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist
药品：rescue antyhypertensive medication
in the case of intraoperative hypertension reluctant to rescue analgesia, rescue intravenous antihypertensive medication using 10 mcg of urapidil will be administered by anaesthesiologist
药品：rescue antyemetic medication
in the case of postoperative nausea and vomitting, rescue intravenous antiemetic medication using 4 mg of ondansetron will be administered by anaesthesiologist
药品：rescue antyhypotensive medication
in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist
药品：rescue antyhypotensive medication
in the case of intraoperative bradycardia, rescue intravenous antihypotensive medication using 500 mcg of atropine will be administered by anaesthesiologist

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
haemodynamic stability
大体时间：intraoperatively
variations of haemodynamic parametres will be analysed
intraoperatively

次要结果测量

结果测量
措施说明
大体时间
pain perception using SPI value variations
大体时间：intraoperatively
pain perception using SPI value variations will be analysed
intraoperatively

其他结果措施

结果测量
措施说明
大体时间
ischaemic stroke
大体时间：from beginning of operation till discharge from hospital
presence of ischaemic stroke will be observed
from beginning of operation till discharge from hospital
dysarthria
大体时间：from beginning of operation till discharge from hospital, approximately 2 - 14 days
presence of dysarthria will be observed
from beginning of operation till discharge from hospital, approximately 2 - 14 days
limb paresis
大体时间：from beginning of operation till discharge from hospital, approximately 2 - 14 days
presence of limb paresis will be observed
from beginning of operation till discharge from hospital, approximately 2 - 14 days
hoarseness
大体时间：from beginning of operation till discharge from hospital, approximately 2 - 14 days
presence of hoarseness will be observed
from beginning of operation till discharge from hospital, approximately 2 - 14 days
face semiparesis
大体时间：from beginning of operation till discharge from hospital, approximately 2 - 14 days
presence of semiparesis will be observed
from beginning of operation till discharge from hospital, approximately 2 - 14 days
postoperative nausea and vomitting
大体时间：from beginning of operation till discharge from hospital, approximately 2 - 14 days
presence of postoperative nausea and vomitting will be observed
from beginning of operation till discharge from hospital, approximately 2 - 14 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Medical University of Silesia

合作者

Silesian University of Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年10月1日

初级完成 (预期的)

2020年10月1日

研究完成 (预期的)

2020年10月1日

研究注册日期

首次提交

2019年4月14日

首先提交符合 QC 标准的

2020年7月31日

首次发布 (实际的)

2020年8月5日

研究记录更新

最后更新发布 (实际的)

2020年8月5日

上次提交的符合 QC 标准的更新

2020年7月31日

最后验证

2020年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SilesianMUKOAiIT4

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

publication in AiIT

IPD 共享时间框架

within a year

IPD 共享访问标准

on a reasonable request

IPD 共享支持信息类型

  • 知情同意书 (ICF)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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