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Regional Haemodynamic Changes in Radial Artery Assessment With Continuous Pulsed-wave Doppler Ultrasound

2020年3月6日 更新者:Wen-fei Tan、China Medical University, China

Regional Haemodynamic Changes in Radial Artery Assessment With Continuous Pulsed-wave Doppler Ultrasound in Patients Undergoing Video-assisted Thoracic Surgery With Different Kinds of Anaesthesia Management

The objective of the trial was to evaluate velocity-associated parameters of pulsed-wave Doppler ultrasound at induction, discharge from the post-anaesthesia care unit and during inspiratory cough in addition to the consumption of phenylephrine during the operation in patients undergoing video-assisted thoracic surgery with three types of anaesthesia management.

研究概览

详细说明

The objective of the trial was to evaluate velocity-associated parameters of pulsed-wave Doppler ultrasound at induction, discharge from the post-anaesthesia care unit and during inspiratory cough in addition to the consumption of phenylephrine during the operation in patients undergoing video-assisted thoracic surgery with three types of anaesthesia management. The patients in this trial were visited during the entire operation and just before leaving the post-anaesthesia care unit. Velocity-associated data related to pulsed-wave Doppler ultrasound and the consumption of phenylephrine were collected.

研究类型

介入性

阶段

  • 第四阶段

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

    • Liaoning
      • Shenyang、Liaoning、中国、110001
        • The First Hospital of China Medical University

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 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. ethnic Chinese;
  2. age, 18 to 65 years old;
  3. American Society of Anaesthesiologists (ASA) physical status I or II;
  4. required VATS for lung surgery and one lung ventilation .

Exclusion Criteria:

body mass index exceeding 30 kg/m2; Patients with a history of hypertension, diabetes mellitus or arteriosclerosis; and any allergy to drugs used in the study.

Patients with arrhythmias or implanted cardiac pacemakers were excluded. Patients with diseases of the central or peripheral nervous system were excluded.

Patients taking medications affecting the autonomic nervous system, such as b-blockers and calcium channel blockers

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
其他:Group control
In the control group, local anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery.
local anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery.
实验性的:Paravertebral Block Group
In Group Paravertebral Block, patients received standardized general anaesthesia supplemented by paravertebral Block. The USG approach for TPVB was used with the patient in the lateral position at the T4-T6 level according to the incision protocol in our centre.
The investigators designed a study to assess whether there were any blood flow indexes change during induction with doppler ultrasonography after 0.5% ropivacaine paravertebral block
实验性的:Epidural Block Group
The investigators designed a study to assess whether there were any blood flow indexes change during induction with doppler ultrasonography ;general anesthesia combined with epidural block
A 4-5 ml bolus of 0.25% ropivacaine was administered 1 h after the initiation of TEB.

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
The Change of end-diastolic velocity
大体时间:baseline and 10 minutes after induction
The primary outcome was the end-diastolic velocity at 12 time points of anaesthesia induction among the three groups.
baseline and 10 minutes after induction

次要结果测量

结果测量
措施说明
大体时间
pulsed-wave Doppler ultrasound
大体时间:before leaving the PACU, up to 5 minutes
other data related to pulsed-wave Doppler ultrasound and acquired during anaesthesia induction, before leaving the PACU and during inspiratory cough
before leaving the PACU, up to 5 minutes
intraoperative consumption of phenylephrine
大体时间:through study completion, an average of 3 hours
intraoperative consumption of phenylephrine
through study completion, an average of 3 hours

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。

调查人员

  • 学习椅:Hong Ma, MD,PhD、Department of Anesthesiology

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)

2017年10月15日

初级完成 (预期的)

2020年8月20日

研究完成 (预期的)

2020年9月20日

研究注册日期

首次提交

2017年10月1日

首先提交符合 QC 标准的

2017年10月3日

首次发布 (实际的)

2017年10月5日

研究记录更新

最后更新发布 (实际的)

2020年3月10日

上次提交的符合 QC 标准的更新

2020年3月6日

最后验证

2020年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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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