Effect of Inhalational Anesthesia Versus Total Intravenous Anesthesia on Blood Glucose Level in Type 2 Diabetes Mellitus Patients Undergoing Thoracic Surgery : a Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Blood glucose levels in milligrams per decilitre (mg/dl) at different time points
研究概览
简要总结
The aim of this study is to compare the effect of total intravenous anesthesia (TIVA) and inhalational anesthesia (IHA) as maintenance anesthesia on blood glucose level and complications in type 2 diabetic patients undergoing thoracic surgery . All participants had to understand and give written informed consent , and ethical committee approval (of Faculty of Medicine, Ain Shams University) will be obtained before participants allocation.
详细描述
- Type of Study: prospective , randomized .
- Study Settings: Ain Shams University hospitals, Cairo, Egypt.
- Study period: 12 months starting from janurary 2024 .
- Study Population: All adult type 2 diabetic patients (30-70 year old) with class II,III based on the American Society of Anesthesiologists (ASA) physical status undergoing elective thoracic surgeries will be randomly assigned into one of the following groups using computer generated codes and opaque sealed envelopes:
- Group A will receive total inravenous anesthesia (TIVA).
- Group B will receive inhalational anesthesia (IHA)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30 - 70 years Sex: Both sexes Pateints with type 2 diabetes mellitus controlled with oral hypoglycemics Patients with ASA classificaion II,III Duration of surgery (≥2 h)
排除标准
- •Declining to give written informed consent ASA classification Ⅳ to V Severe systemic diseases Metabolic disorders, diabetic ketoacidosis or hyperglycemia (fasting blood glucose more than 140 mg/dl) Hepatic and/or renal dysfunction Neuromuscular disease Pancreatic cancer History of malignant hyperthermia Emergency surgery Ischemic heart disease and valvular heart disease Body mass index more than 40 Diabetic patients on insulin therapy
研究组 & 干预措施
Group B will receive inhalational anesthesia (IHA)
patients in this group will receive inhalational anesthesia using isoflurane, tested variables will be measured according to the protocol
干预措施: Inhalational anesthesia (Drug)
结局指标
主要结局
Blood glucose levels in milligrams per decilitre (mg/dl) at different time points
时间窗: Immediate preoperative till 48 hours after recovery from anesthesia
Blood glucose levels in milligrams per deciliter at different time points: preoperative (T0), post-intubation (T1), 1st , 2nd and 3rd hour after the start of the operation (T3, T4 and T5, respectively), 1st hour after the operation (T6) , 2nd hour after the operation (T7), 1st and 2nd day after the operation (T8, T9)
次要结局
- The incidence of postoperative complications(The complications will be assessed on the first, third and seveth post-operative day)
- Serum insulin level in picomoles per litre (pmol/l)(30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia)
- Serum cortisol level in micrograms per decilitre (mcg/dl)(30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia)
研究者
Yasser Alaa Abdalmonim
Principal Investigator
Ain Shams University