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临床试验/NCT03653494
NCT03653494Unknown早期 1 期

Department of Anesthesiology in Shenzhen People's Hospital

Shenzhen People's Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
发起方
入组人数
80
试验地点
1
主要终点
the volume of anesthetic drugs

研究概览

简要总结

Putting 80 patients divided into group S(non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia and Vagus block) and group D(non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia、Vagus block and Phrenic block)randomly,compare the volume of anesthetic and the number of increasing anesthetic during operation were compared between the two groups.If the date of group S greater than group D,it shows that the effect of anesthetic effect of group D is better than group S.

详细描述

  1. Put 80 patients divided into group S(non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia and Vagus block) and group D(non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia、Vagus block and Phrenic block)randomly.
  2. Compare the volume of anesthetic drugs between the two groups.
  3. If the date of group S greater than group D,it shows that the effect of anesthetic effect of group D is better than group S.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Volunteers and data collectors was masked

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

  • The patient agreed to perform non-intubated video-assisted thoracoscopic surgery, and informed the possibility of intraoperative tracheal intubation or thoracotomy.
  • No conventional anesthesia contraindication, no history of thoracic surgery, good cardiopulmonary function.
  • There is no severe adhesion and calcification in the thoracic cavity, and no artificial pneumothorax is affected.
  • the patient has no serious anxiety or depression.
  • Small surgical trauma, simple steps, short time.

排除标准

  • Mallampati≥
  • BMI≥26 kg/m
  • Hemodynamic instability.
  • Respiratory infection, persistent cough or airway mucus hypersecretion, high risk of reflux.
  • nervous system disease,such as seizure or brain edema.
  • Extensive pleural adhesions or once chest surgery.
  • PaO2<60mmHg or PaCO2>50 mmHg.
  • Central hypopnea syndrome.
  • Lung isolation should be used to protect the healthy side of the lung.
  • Complicated operation, large trauma, long time, lack of experience or poor cooperation in the surgical team.
  • Contraindications to local anesthetic.

研究组 & 干预措施

phrenic block group

Experimental

non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia、Vagus block and Phrenic block

干预措施: phrenic block (Procedure)

Control group

Active Comparator

non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia and Vagus block

干预措施: no phrenic block (Procedure)

结局指标

主要结局

the volume of anesthetic drugs

时间窗: the time of operation, an average of 4 hours

the volume of anesthetic drugs including sevoflurane,propofol and opioids during the operation

次要结局

  • the time to get out of bed after surgery(two days after surgery)
  • the cost of hospitalization(the time of hospitalization, an average of 7 days)

研究者

发起方
Shenzhen People's Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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