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临床试验/NCT03048162
NCT03048162已完成不适用

The Evaluation of the Effects of Intravenous Fluids on Perfusion Index and Pleth Variability Index

Tokat Gaziosmanpasa University1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2017年2月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
93
试验地点
1
主要终点
Perfusion index

研究概览

简要总结

This study is aimed to assess the effects of intravenously administered three fluid types on perfusion index and pulse variability index in patients during preoperative period. Patients will be randomly divided into three groups. Baseline, 5th, 10th, 15th, 20th, 25th and 30th min non-invasive blood pressure, oxygen saturation, heart rate, room temperature, perfusion index and pulse variability index will be measured and recorded.

详细描述

Intravenous volume replacement alter the dynamics of microcirculation. Perfusion index and pulse variability index are the recent parameters to evaluate the tissue microcirculatory condition. This study is aimed to assess the effects of intravenously administered three fluid types on perfusion index and pulse variability index in patients during preoperative period. Patients will be taken to recovery room in the operating theatre and wait for 15 minutes to balance the skin temperature of the patients to the environment. Patients will be randomly divided into three groups using closed envelope technique as Group L (received 500 ml of Ringer's lactate), Group S (500 ml of saline) and Group H (received 500 ml of 6% hydroxyethylstarch). Baseline, 5th, 10th, 15th, 20th, 25th and 30th min non-invasive blood pressure, oxygen saturation, heart rate, room temperature, perfusion index and pulse variability index will be measured and recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • having a fasting period of 8 hours
  • quit smoking for 8 hours before the procedure

排除标准

  • not to participate in the study
  • presence of peripheral vascular disease
  • a history of upper extremity surgery
  • presence of any kind of psychiatric disease

研究组 & 干预措施

sodium chloride

Active Comparator

0.9% isotonic sodium chloride, 500 ml, one package in 30 minutes

干预措施: sodium chloride (Drug)

Hydroxyethylstarch

Active Comparator

6% hydroxyethylstarch, 500 ml, one package in 30 minutes

干预措施: Hydroxyethylstarch (Drug)

Ringer-Lactate Infusion Solution Bag

Active Comparator

Ringer's lactate, 500 ml, one package in 30 minutes

干预措施: Ringer-Lactate Infusion Solution Bag (Drug)

结局指标

主要结局

Perfusion index

时间窗: six months

The perfusion of the tissues

次要结局

  • Pulse variability index(six months)
  • Blood pressure(six months)
  • Heart rate(six months)
  • Oxygen saturation(six months)

研究者

发起方
Tokat Gaziosmanpasa University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Serkan Dogru

Assistant Professor

Tokat Gaziosmanpasa University

研究点 (1)

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