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临床试验/NCT03302221
NCT03302221撤回4 期

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

China Medical University, China1 个研究点 分布在 1 个国家开始时间: 2017年10月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
The Change of end-diastolic velocity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Group control

Other

In the control group, local anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery.

干预措施: 0.5% ropivacaine local anaesthesia (Drug)

Paravertebral Block Group

Experimental

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.

干预措施: 0.5% ropivacaine paravertebral block (Drug)

Epidural Block Group

Experimental

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

干预措施: 0.25% ropivacaine epidural block (Drug)

结局指标

主要结局

The Change of end-diastolic velocity

时间窗: 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.

次要结局

  • pulsed-wave Doppler ultrasound(before leaving the PACU, up to 5 minutes)
  • intraoperative consumption of phenylephrine(through study completion, an average of 3 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wen-fei Tan

Associate proffesor

China Medical University, China

研究点 (1)

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