跳至主要内容
临床试验/NCT02154074
NCT02154074Unknown4 期

Dexmedetomidine Influence on the Level of Perioperative Blood Glucose and Insulin of Elderly Diabetes Patients

Second Affiliated Hospital of Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
92
试验地点
1
主要终点
blood glucose

研究概览

简要总结

Dexmedetomidine is a kind of high selectivity alpha 2 agonists adrenaline, can inhibit the activity of sympathetic nerve, alleviate pain,and improve cardiovascular stability in the operation period. Dexmedetomidine have influence on perioperative stress response and immune function,but it is not clear.

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
None

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 60 to 80 years old;
  • Type 2 diabetes;
  • Not use insulin treatment;
  • Onging general anesthesia surgery;
  • Surgery time 1-3 hours

排除标准

  • ASA classification > class II;
  • Hypertension;
  • Serious central nervous system diseases (acute stroke, uncontrolled seizures, -Severe dementia);
  • Unstable angina and acute myocardial infarction;
  • Allergy to investigational drug;
  • Hepatic and renal dysfunction

研究组 & 干预措施

N1 group: Isoflurane & saline

Active Comparator

for normal patients: inhale Isoflurane + the same volume of saline during operation

干预措施: general anesthesia induction (Drug)

N1 group: Isoflurane & saline

Active Comparator

for normal patients: inhale Isoflurane + the same volume of saline during operation

干预措施: Isoflurane (Drug)

N1 group: Isoflurane & saline

Active Comparator

for normal patients: inhale Isoflurane + the same volume of saline during operation

干预措施: normal saline (Drug)

N2 group: Isoflurane & Dexmedetomidine

Experimental

for normal patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation

干预措施: general anesthesia induction (Drug)

N2 group: Isoflurane & Dexmedetomidine

Experimental

for normal patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation

干预措施: Isoflurane (Drug)

N2 group: Isoflurane & Dexmedetomidine

Experimental

for normal patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation

干预措施: Dexmedetomidine (Drug)

D1 group: Isoflurane & saline

Active Comparator

for diabetes patients: inhale Isoflurane + the same volume of saline during operation

干预措施: general anesthesia induction (Drug)

D1 group: Isoflurane & saline

Active Comparator

for diabetes patients: inhale Isoflurane + the same volume of saline during operation

干预措施: Isoflurane (Drug)

D1 group: Isoflurane & saline

Active Comparator

for diabetes patients: inhale Isoflurane + the same volume of saline during operation

干预措施: normal saline (Drug)

D2 group: Isoflurane & Dexmedetomidi

Experimental

for diabetes patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation

干预措施: general anesthesia induction (Drug)

D2 group: Isoflurane & Dexmedetomidi

Experimental

for diabetes patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation

干预措施: Isoflurane (Drug)

D2 group: Isoflurane & Dexmedetomidi

Experimental

for diabetes patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

blood glucose

时间窗: from the day before surgery to 24 hours after surgery

measure blood glucose at 3 time points,the day before surgery,Intraoperative(1 hour after surgery begain),one day after surgery(24 hours after surgery); examine the concentration of blood glucose in serum.

level of blood insulin

时间窗: from the day before surgery to 24 hours after surgery

measure the level of blood insulin at 3 time points,the day before surgery,Intraoperative(1 hour after surgery begain),one day after surgery(24 hours after surgery); use ELISA to examine the concentration of blood insulin in serum.

次要结局

  • vital signs(duration of perioperative period)

研究者

发起方
Second Affiliated Hospital of Xi'an Jiaotong University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验