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临床试验/NCT04806997
NCT04806997已完成不适用

Changes in the Microvascular Reactivity on Leg During Spinal Anesthesia

Pusan National University Hospital1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2016年12月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Change of recovery slope between baseline and after spinal anesthesia

研究概览

简要总结

Anesthesia alters microcirculation and tissue oxygen saturation (StO2). We sought to examine changes in StO2 using near-infrared spectroscopy and a vascular occlusion test (VOT) during spinal anesthesia. This prospective observational study was included 51 patients without comorbidities who underwent elective surgery under spinal anesthesia. We measured the StO2 in the lower extremity during VOT before and after intrathecal injection.

详细描述

The vascular occlusion test (VOT) procedure was conducted twice in each patient, before and 15 min after intrathecal injection. An near-infrared spectroscopy (NIRS) sensor (INVOSTM 5100C Cerebral/Somatic Oximeter; Medtronic, Minneapolis, MN, USA) was attached to the patient's gastrocnemius muscle. A tourniquet (A.T.S ® 3000 Automatic Tourniquet System; Zimmer Inc., Warsaw, IL, USA) was applied to the thigh and inflated to a pressure value 50 mmHg over the patient's baseline systolic blood pressure in the leg and maintained for 5 min. After a 5-min ischemic period, the tourniquet was rapidly deflated to 0 mmHg. The tissue oxygen saturation (StO2) data was continuously recorded during the VOT procedure. After confirmation of spinal anesthesia using cold sensitivity, the VOT procedure was repeated in the same manner as mentioned above. The occlusion slope and recovery slope were calculated based on the measured StO2 data. The occlusion slope was defined as the descending slope of StO2 value until it reached the minimum value. The recovery slope was calculated from the deflation of the tourniquet until the recovery of StO2 to the maximum value.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The patients who were scheduled for spinal anesthesia
  • 18< age < 60 years old

排除标准

  • American Society of Anesthesiologists physical status class > III,
  • allergy or sensitivity to study medications,
  • alcohol or drug abuse history,
  • body mass index > 35 kg/ m2 or < 15 kg/m2,
  • p regnancy or breastfeeding status,
  • diabetes and on insulin treatment,
  • untreated or uncontrolled arterial hypertension,
  • peripheral arterial disease,
  • corticosteroid treatment, coagulopathy, and lower limb deformities or burns
  • patients who may not tolerate VOT

结局指标

主要结局

Change of recovery slope between baseline and after spinal anesthesia

时间窗: baseline and immediately after spinal anesthesia

Recovery slope is related to microvascular reactivity, was calculated from the deflation of the tourniquet until the recovery of tissue oxygen saturation to the highest value

次要结局

未报告次要终点

研究者

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

Hyae-Jin Kim

Associate professor

Pusan National University Hospital

研究点 (1)

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