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临床试验/NCT03074955
NCT03074955Unknown不适用

Preventive Effect of Leg Wrapping Combined With Trendelenburg Position on Hypotension Induced by Propofol

Hyungmook Lee2 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2013年8月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
156
试验地点
2
主要终点
SBP_2

研究概览

简要总结

Although propofol is widely used as an induction agent for a general anesthesia, it can induce a profound hypotension, which leads to the hypo-perfusion of end organs and eventually increases morbidities. Theoretically, applying Trendelenburg position (head down and leg up position) increases cardiac preloads and cardiac outputs. However, in past researches, changing to Trendelenburg position alone is not enough and does not prevent propofol induced hypotension. Previous studies proved that leg wrapping effectively prevent hypotension after neuraxial anesthesia during Cesarean section. The leg wrapping prevents hypotension by increasing vascular resistance of lower extremities. The investigators made a hypothesis that applying both Trendelenburg position and leg wrapping prevent propofol induced hypotension more effectively than either applying Trendelenburg position only or taking no preventive measures.

详细描述

** Study procedure

  1. check baseline blood pressure ( systolic, diastolic, mean) and heart rate.
  2. apply pre-defined measures to each group(arm) ( summarized in arms and interventions section )
  3. induction using propofol 2mg/kg
  4. After bispectral index (BIS) goes below 60 & patient become unconsciousness, inject rocuronium 0.6mg/kg
  5. intubate patient between 3 and 4 minutes after propofol injection
  6. measure blood pressure ( systolic, diastolic, mean ) & heart rate at 1,2,3,4,5 minutes after propofol injection
  7. phenylephrine injection if hypotension develops

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologist's physiologic status class 1, 2, and
  • under general anesthesia

排除标准

  • severe cardiac/pulmonary/liver/renal disease
  • BMI > 30 kg/m2
  • known or risk factor of increased intraocular pressure or intracranial pressure
  • uncontrolled hypertension
  • high risk for propofol allergy
  • allergies to medications related to anesthesia
  • mechanical difficulties with leg wrapping ( wound on legs, devices on legs )
  • emergent operation
  • high risk of gastric aspiration ( gastrointestinal obstruction, short nil per os(NPO) time )
  • patient wearing elastic stocking for therapeutic purpose

结局指标

主要结局

SBP_2

时间窗: 2 minutes from propofol injection

systolic blood pressure at 2 minutes from propofol injection

次要结局

未报告次要终点

研究者

发起方
Hyungmook Lee
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hyungmook Lee

professor

Seoul St. Mary's Hospital

研究点 (2)

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