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临床试验/CTRI/2018/03/012821
CTRI/2018/03/012821已完成不适用

Intraoperative blood Glucose level cnanges between obese and non-obese non-diabetic patients undergoing general anaesthesia for craniotomy surgery

Department of Anaesthesiology Bangur Institute of Neurology IPGMER SSKMH1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年3月3日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
blood glucose level changes will be more in obese than in non-obese population and the change will increase with the duration of surgery

研究概览

简要总结

Background: Surgery causes a considerable metabolic stress in both diabetic and nondiabetic patient, but the   severity of stress induced hyperglycemia is considerably high in diabetic  patient  . In non-diabetic subjects the stress response is more in obese population than in non-obese due to the presence of insulin resistance. The severity of surgery as well as the type of anesthesia influence the magnitude of the stress response The study was undertaken to observe the effect of stress   in obese and non-obese non-diabetic patients undergoing craniotomy under general anesthesia. Methods: A Prospective randomized parallel group study was done on a total of 100 patients. They were divided into two groups non-obese patients and obese patients comprising of 50 patients in each group depending on their BMI. If at any time intraoperative CBG was found to be more than or equal to 150 mg/dL calculated  dose of human soluble insulin was given as intravenous bolus equal to the amount of CBG/100 units. Number of hyperglycaemic episode and total insulin consumption in both group were the primary outcome of study. Results: 36% patients in obese population developed at least one episode of hyperglycemia (CBG ≥ 150 mg/dL) whereas only 20% patients in non-obese population had hyperglycemia episode .   The relative risk of  hyperglycemic in obese was higher than non-obese [ 1.80 (95% CI 0.92 to 3.51)]. The total intraoperative  and postoperative insulin requirement were significantly higher  in non-obese population  than obese  and the difference was statistically significant (p=0.02) Conclusions: We conclude that stress induced hyperglycemic response in patients undergoing craniotomy surgery under general anaesthesia is common in both   diabetic and non-diabetic population  and the relative risk  is more in  obese patients than non-obese.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status I and II
  • non-diabetic obese patients undergoing craniotomy surgery under general anaesthesia
  • non-diabetic non-obese patients undergoing craniotomy surgery under general anaesthesia.

排除标准

  • unwilling patients
  • patients with severe cardiovascular, respiratory, renal and endocrine disease including diabetes mellitus
  • all emergency surgeries
  • surgeries other than neurosurgical procedures
  • operations under regional anaesthesia
  • hemodynamically unstable patients
  • pregnancy
  • ASA physical status III or more
  • age <18 yrs and >65 yrs.

结局指标

主要结局

blood glucose level changes will be more in obese than in non-obese population and the change will increase with the duration of surgery

时间窗: preoperative single value, just after induction of anaesthesia and thereafter at half an hour interval till the end of operation, single value postoperatively 30 minutes after extubation

次要结局

  • insulin requirement will be more in obese than in non-obese patients and the requirement will increase with the duration of surgery(180 minutes)

研究者

发起方
Department of Anaesthesiology Bangur Institute of Neurology IPGMER SSKMH
申办方类型
Government medical college

研究点 (1)

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