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临床试验/CTRI/2025/08/093202
CTRI/2025/08/093202招募中不适用

Effect of preoperative oral carbohydrate on perioperative blood glucose in Indian patients with type 2 diabetes mellitus scheduled for surgery under general anaesthesia - a randomized controlled study

university college of medical sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月18日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Blood Glucose level

研究概览

简要总结

Patients undergoing elective surgery are subjected to prolonged period of fasting in view of risk of pulmonary aspiration. Preoperative fasting state leads to a catabolic state, which adds to patient discomfort and delayed mobilization. Prolonged fasting and surgical trauma enhance the release of stress hormone, which leads to the development of hyperglycemia and insulin resistance (IR). Preoperative oral carbohydrate (POC) has shown beneficial effects in postoperative patient outcome and in decreasing hyperglycemia and IR. But, the effect of POC administration in Indian patients with Type 2 diabetes mellitus (DM) still remains inconclusive. Therefore, in this study we aim to see the effect of preoperative oral carbohydrate on perioperative blood glucose in Indian patients with Type 2 DM scheduled for surgery under general anaesthesia. The study will be conducted after obtaining approval from Institutional Ethics Committee-Human Research and written and informed consent. Patient will be asked to omit oral hypoglycemic agents as routinely done before surgery. Last meal time will be  noted for all the patients. An independent anaesthesiologist not involved in the further management of the patient will administer the carbohydrate drink/water as per group allocation based on a computer generated table of random numbers. Group A: Patients in this group will remain nil per orally for solids for at least 6 hours and will receive 296 ml drinking water 2 hrs before surgery. Group B: Patients in this group will remain nil per orally for solids for at least 6 hours and will receive 296 ml of oral carbohydrate solution containing 50g maltodextrin (Energizer-Neon laboratories) 2 hours before surgery. Patients will be taken inside the operating room where routine monitoring will be initiated. General anaesthesia will be given and the surgery will be allowed to proceed. Hourly glucose measurements will be done (capillary blood glucose). Blood samples will be collected for the estimation of serum insulin for the calculation of insulin resistance. Intraoperatively insulin will be administered as per Vellore regime to maintain blood glucose <180 mg/dL.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients older than 18 years with type II diabetes, with HbA1c less than 7 (within last month) and fasting blood glucose on the morning of surgery within 80-180 mg/dL scheduled for elective surgery under general anaesthesia will be included.

排除标准

  • Patients with any of the following will be excluded: 1.Known case of T1DM, Type II DM requiring insulin therapy, pheochromocytoma, carcinoid tumor etc.
  • 2.H/o pancreatitis, alcoholism, jaundice or liver disorders 3.Obesity (BMI more than 30 kg/m2) 4.Patients with history of gastro-oesophageal reflux, gastric outlet/intestinal obstruction, emergency surgery, pregnant females 5.Patients on continuous steroid therapy for more than 5 days in the last one year.
  • 6.Unwilling to participate in the study.

结局指标

主要结局

Blood Glucose level

时间窗: Once, 2 hours after preoperative drink

次要结局

  • Perioperative glucose control
  • Insulin level(T0-fasting serum insulin levels)
  • Insulin resistance(T0-fasting)
  • Post operative nausea and vomiting(0-2 hours)
  • Post-surgery recovery pattern

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Vishal Sharma

University college of medical sciences

研究点 (1)

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