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临床试验/NCT02510612
NCT02510612Unknown4 期

Perioperative Dexmedetomidine Affect Diabetic Patient's Glucose Metabolism

Shaanxi Provincial People's Hospital0 个研究点目标入组 120 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
120
主要终点
sedation level

研究概览

简要总结

Dexmedetomidine's Sedative Effect on Diabetic Patient

详细描述

Dexmedetomidine is a high selective α2 agonist,its sedative and analgesia feature is acclaimed. The pathogenesis of type 2 diabetes mellitus is associated with α2 excessive adrenaline receptors expression. This study is to evaluate whether the use of dexmedetomidine is helpful to Diabetic Patient through its antisympathetic effect

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Age between 40 and 60
  • Selective epigastrium surgery

排除标准

  • American Society of Anesthesiology (ASA) Physical Status>3
  • Duration of operation >3 hours
  • Hypovolemia,sinus bradycardia,atrioventricular block,severe hepatic and renal dysfunction,severe cardiac insufficiency

研究组 & 干预措施

Dexmedetomidine

Experimental

Patients in group D will be given dexmedetomidine during anesthesia induction and maintenance phase respectively.In induction phase infuse 1μg/Kg of dexmedetomidine in 10 minutes, the speed in maintenance phase is 0.4μg/Kg.h

干预措施: Dexmedetomidine (Drug)

placebo

Placebo Comparator

Patients in group P will be given normal saline during anesthesia induction and maintenance phase

干预措施: placebo (Drug)

结局指标

主要结局

sedation level

时间窗: from 5 minutes before medication to 10 minutes after Dexmedetomidine discontinuance,length of time frame is about 2 hours

Ramsay score and BIS will be recorded before medication,5 min after medication, medication ending, 5 and 10 min after medication

次要结局

  • Mean arterial pressure(participants will be followed from operation day to first postoperative day,an expected average of 2 days)
  • cortisol measured by Biochemical test(participants will be followed from operation day to first postoperative day,an expected average of 2 days)
  • adrenaline measured by Biochemical test(participants will be followed from operation day to first postoperative day,an expected average of 2 days)
  • noradrenaline measured by Biochemical test(participants will be followed from operation day to first postoperative day,an expected average of 2 days)
  • blood glucose measured by Biochemical test(participants will be followed from operation day to first postoperative day,an expected average of 2 days)
  • Heart rate(participants will be followed from operation day to first postoperative day,an expected average of 2 days)
  • insulin measured by Biochemical test(participants will be followed from operation day to first postoperative day,an expected average of 2 days)

研究者

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

Song yulong

Anesthetist

Shaanxi Provincial People's Hospital

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