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临床试验/NCT03612440
NCT03612440Unknown不适用

Effects of Dexmedetomidine on Oxygenation Index, Respiratory Index and Inflammatory Factors in Patients Undergoing Palatopalatyngoplasty

General Hospital of Ningxia Medical University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年8月1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
发起方
入组人数
80
试验地点
1
主要终点
The Respiratory Index

研究概览

简要总结

The purpose of this study is to investigate the efficacy of dexmedetomidine on oxygenation index, respiratory index and inflammatory factors, and to explore the protective effect of the dexmedetomidine on respiratory function in patients undergoing palatopalatyngoplasty.

详细描述

Obstructive sleep apnea syndrome is common among people, especially among obese people, Which is characterized by periodic or complete upper airway obstruction and hypoxia during sleep. Intermittent hypoxia contributes to the lung damage by increased oxidative stress, inflammation. Some researchers suggested that dexmedetomidine can inhibit inflammatory reaction and lessen the damage of respiratory function. The aim of this study is to investigate the efficacy of dexmedetomidine on oxygenation index, respiratory index and inflammatory factors, and to explore the protective effect of the dexmedetomidine on respiratory function in patients undergoing palatopalatyngoplasty.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing palatopalatyngoplasty
  • ASA physical status II-III
  • Aged 18-65 years
  • BMI 18.5-30kg/m2

排除标准

  • Bradycardia
  • Atrioventricular block
  • Allergic to the drugs
  • Complicating pulmonary disease(including pulmonary infection,COPD, asthma and so on)

研究组 & 干预措施

Group D

Experimental

40 patients receive a loading infusion of dexmedetomidine (1ug/kg)for 20min follow by a maintenance infusion (0.4ug/kg/h) continued until the end of the surgery

干预措施: dexmedetomidine (Drug)

Group C

Placebo Comparator

40 patients receive matching placebo (normal saline)

干预措施: normal saline (Other)

结局指标

主要结局

The Respiratory Index

时间窗: Intraoperative and immediately after surgery

Arterial blood samples were sampled before anaesthesia induction and immediately after surgery for the respiratory index by using blood gas analyzer.

The Oxygenation Index

时间窗: Intraoperative and immediately after surgery

Arterial blood samples were sampled before anaesthesia induction and immediately after surgery for the oxygenation index by using blood gas analyzer.

次要结局

  • Change of tumor necrosis factor-α before anesthesia and immediately after surgery(Intraoperative and immediately after surgery)
  • Change of interleukin-6 before anesthesia and immediately after surgery(Intraoperative and immediately after surgery)
  • Change of interleukin-10 before anesthesia and immediately after surgery(Intraoperative and immediately after surgery)

研究者

发起方
General Hospital of Ningxia Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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