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临床试验/NCT03060798
NCT03060798已完成不适用

The Change of Tissue Oxygen Saturation Measured by Dynamic Near Infrared Spectroscopy Following Volatile Anesthesia in Healthy Population

Pusan National University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年8月2日最近更新:
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试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Changes in Tissue Oxygen Saturation after General Anesthesia

研究概览

简要总结

General anesthesia can affect tissue oxygen saturation and microcirculatory reactivity. However, the differences in microcirculation caused by anesthetic methods have not been well studied. Near-infrared spectroscopy (NIRS) measures peripheral tissue oxygen saturation noninvasively and can be used in conjunction with vascular occlusion (VOT) experiments. The purpose of this study was to examine the changes in NIRS derived tissue oxygen saturation (StO2) and microcirculatory reactivity by VOT after inhalation anesthesia in healthy population.

This prospective, observational study will be performed on 60 healthy patients who had undergone elective surgery under volatile general anesthesia. The investigators measure StO2 and microvascular reactivity using NIRS combined with vascular occlusion test (VOT). The parameters were performed twice per patient, before and after the induction of anesthesia.

Occlusion slope and recovery slope during VOT will be compared before and after anesthesia. Moreover, the changes depend on the age will be analyzed.

详细描述

This prospective observational study was performed on 60 patients without comorbidities who underwent elective surgery under general anesthesia. Before and after the induction of anesthesia, StO2 monitoring and VOT were performed to investigate the effect of anesthesia on microcirculation. To investigate the effect of age on microcirculation, the patients were divided into two different groups, young (< 65 yrs) and old (> 65 yrs) groups, and the VOT-derived parameters and hemodynamics between two groups were compared.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult Over 18 years of age undergoing general surgery under general anesthesia.

排除标准

  • ASA category III or IV, Diabetes, Chronic Kidney Disease, Vascular Disease

结局指标

主要结局

Changes in Tissue Oxygen Saturation after General Anesthesia

时间窗: before and 30 minutes after anesthetic induction

Vascular occlusion test (VOT) will be performed twice for each patient, before (T0) and 30 min after the induction of general anesthesia (T1). Before induction, a NIRS sensor will be placed on the thenar eminence and an automated tourniquet will be placed around the ipsilateral upper arm. After the baseline StO2 stabilization, the automatic tourniquet will be inflated to 50 mmHg over the patient's baseline systolic blood pressure and maintain for 5 min. After the 5-min ischemic period, the tourniquet will be rapidly deflated to 0 mmHg. StO2 data will be continuously recorded during the VOT procedure. Baseline StO2, minimum StO2 during the 5-min inflation of the tourniquet, maximum StO2 during deflation of the tourniquet, time to minimum StO2, and time to maximum StO2 will be obtained. The occlusion slope and recovery slope will be calculated based on the measured StO2 data.

次要结局

  • Age-related changes in microcirculation(before and 30 minutes after anesthetic induction)

研究者

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

Hyeon-Jeong Lee

Associate Professor

Pusan National University Hospital

研究点 (1)

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