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临床试验/CTRI/2013/02/003342
CTRI/2013/02/003342招募中不适用

Perioperative glycemic status of non diabetic adult traumatic brain injury patients undergoing craniotomy

Institute of Post Graduate Medical Education Research Kolkata1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年1月29日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
intraoperative blood glucose levels in nondiabetic adult patients of TBI undergoing craniotomy in the perioperative period

研究概览

简要总结

Physiologic alterations due tosurgical stress are widespread and affect all organ system of the body.1Of all these changes, the metabolic changes appear to be proportional tothe severity of the surgical trauma with plasma cortisol and blood glucoseconcentration rising slightly during minor surgical procedures butsignificantly during major intraabdominal operations.2 Duringsurgery there is insulin resistance due to rise of levels of counter regulatoryhormones like glucagon, growth hormone, cortisol and catecholamines which canbe indirectly observed by the incidence of hyperglycemia.3

However, hyperglycemia is almost always detrimental, associated withincreased morbidity and mortality even in nondiabetic patients4-6. Severalstudies showed that hyperglycemia is a poor prognostic marker after traumaticbrain injury.7 But none of these studies addressed the incidence ofhyperglycemia in the perioperative period in non diabetic patients.

The present study will be undertaken to know the prevalence ofperioperative hyperglycemia in adult patients of traumatic brain injuryundergoing craniotomy.

Specific objectives of the study:

1.     Toknow the intraoperative blood glucose levels in nondiabetic adult patients ofTBI undergoing craniotomy in the perioperative period

2.     Toknow the blood glucose variability in these patients in the intraoperativeperiod.

3.     Toknow the incidence of at least one episode of intra operative hyperglycemia.

研究设计

研究类型
Observational

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Nondiabetic patients of ASA physical status I, II or III of age group 25-60 years of either sex undergoing craniotomy under general anaesthesia.

排除标准

  • Unwilling patients Patients with known history of diabetes mellitus, impaired postprandial glucose tolerance (2h postprandial blood glucose> 126mg/dL) and impaired fasting glucose (fasting blood glucose> 106mg/dL) Patients with severe respiratory, cardiovascular, neurological or renal disease ASA physical status IV and V Haemodynamically unstable patients Pregnancy Body weight < 40 kg Body weight > 80 kg.

结局指标

主要结局

intraoperative blood glucose levels in nondiabetic adult patients of TBI undergoing craniotomy in the perioperative period

时间窗: 1. Before induction of anaesthesia | 2. Thirty minutes interval till the end of surgery | 3. One hour after conclusion of surgery

次要结局

  • 1.the blood glucose variability in these patients in the intraoperative period.(2. incidence of at least one episode of intra operative hyperglycemia.)

研究者

发起方
Institute of Post Graduate Medical Education Research Kolkata
申办方类型
Government medical college

研究点 (1)

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