Comparison of the stress response between total intravenous anaesthesia (TIVA) and inhalational anaesthetic technique in diabetic patients undergoing abdominal surgery using cortisol/ dehydroepiandrosterone sulphate (DHEAS) ratio
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Serum cortisol to DHEAS ratio before and after the surgery and comparing the values between the total intravenous anaesthesia and inhalational anaesthesia groups in T2DM patients.
研究概览
简要总结
In this study, we plan to measure the surgical stress response in diabetic patients undergoing elective abdominal surgeries in Lok Nayak Hospital, Delhi, using serum cortisol to dehydroepiandrosterone (DHEAS) ratio, serum insulin, serum C-peptide and glucose levels. The comparison will be done between two anaesthetic techniques- total intravenous anaesthesia (TIVA) and inhalational anaesthesia. A total of 76 patients will be enrolled in the study, with 38 patients in each group. The blood samples will be collected 30 minutes prior to the surgery and 24 hours after the completion of surgery. In addition to the surgical stress response, patient outcomes and post-operative complications will also be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA II or III
- •Well controlled type 2 diabetic patients using oral hypoglycaemic agents or insulin.
- •Elective open abdominal surgery.
- •Duration of surgery 2 to 6 hours.
排除标准
- •Diabetic ketoacidosis or diabetic neuropathy.
- •Hepatic and/or renal dysfunction.
- •Pancreatic cancer or islet cell tumours.
- •Patients receiving drugs with known effects on sympathetic response or hormonal secretion such as beta blockers.
结局指标
主要结局
Serum cortisol to DHEAS ratio before and after the surgery and comparing the values between the total intravenous anaesthesia and inhalational anaesthesia groups in T2DM patients.
时间窗: 30 minutes before surgery | 24 hours after completion of surgery
次要结局
- Serum glucose, insulin and C-peptide in diabetic patients receiving intravenous or inhalational anaesthesia at different points of time.(30 minutes before surgery)
- Percentage of post operative complications and outcomes in TIVA and inhalational anaesthetic techniques in diabetic patients undergoing abdominal surgery using EPCO definitions at 24 hours after surgery.(24 hours after completion of surgery)
研究者
Dr Shivika Malik
Maulana Azad Medical College, New Delhi