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临床试验/NCT05749978
NCT05749978招募中不适用

Effects of Postural Adjustment on Hemodynamics in Patients Undergoing Prone Spine Surgery Under General Anesthesia

Zhuan Zhang1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Changes in the level of Cardiac output

研究概览

简要总结

The prone position is a special position often used for spinal surgery. As a special position of general anesthesia, after induction of general anesthesia, severe hemodynamic fluctuations often occur when the supine position is changed to the prone position, which seriously affects the patient's circulatory and respiratory functions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Prone spine surgery after general anesthesia is planned.
  • Age 18~85 years old.
  • ASA grade I or II.
  • BMI18.3-30kg/m2

排除标准

  • Unstable angina or myocardial infarction, coronary heart disease, congestive heart failure, structural heart disease, arrhythmia within 6 months;
  • Increased intracranial pressure and central nervous system injury or disease;
  • Severe hypertension
  • Patients with other diseases affecting their own circulatory system.
  • Have or have a history of severe mental disorders;
  • Bleeding volume >600ml or intraoperative blood transfusion treatment.
  • Severe liver and kidney insufficiency

结局指标

主要结局

Changes in the level of Cardiac output

时间窗: Preoperatively,5 minute after anesthesia induction,Immediately before the prone position, Immediately after the prone position,1 minute after prone position, 3 minute after prone position,10 minute after prone position,Half an hour after prone position

Cardiac output

Change in Blood pressure

时间窗: Preoperatively,5 minute after anesthesia induction,Immediately before the prone position, Immediately after the prone position,1 minute after prone position, 3 minute after prone position,10 minute after prone position,Half an hour after prone position

Hemodynamics

次要结局

  • Intra-abdominal pressure level(Preoperatively,5 minute after anesthesia induction,Immediately before the prone position, Immediately after the prone position,1 minute after prone position, 3 minute after prone position,10 minute after prone position,Half an hour after prone position)
  • Vasoactive drugs(Intraoperatively)

研究者

发起方
Zhuan Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhuan Zhang

Principal Investigator

Yangzhou University

研究点 (1)

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