Effect of Inhalational Anesthesia Versus Total Intravenous Anesthesia on Blood Glucose in Type 2 Diabetes Patients
- Conditions
- Type 2 Diabetes Mellitus (T2DM)Thoracic Surgery
- Interventions
- Drug: Inhalational anesthesia
- Registration Number
- NCT06613893
- Lead Sponsor
- Ain Shams University
- Brief Summary
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.
- Detailed Description
* 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:
1. Group A will receive total inravenous anesthesia (TIVA).
2. Group B will receive inhalational anesthesia (IHA)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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)
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B will receive inhalational anesthesia (IHA) Inhalational anesthesia patients in this group will receive inhalational anesthesia using isoflurane, tested variables will be measured according to the protocol
- Primary Outcome Measures
Name Time Method Blood glucose levels in milligrams per decilitre (mg/dl) at different time points 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)
- Secondary Outcome Measures
Name Time Method The incidence of postoperative complications The complications will be assessed on the first, third and seveth post-operative day The complications that will be tested Acute coronary syndrome. Stroke. acute kidney injury. stress gastric ulcer. surgical site infection. Hypoglycaemia (blood glucose level below 70 mg/dL). Hyperglycemia (fasting blood glucose level greater than 125mg/dL while 2 hours postprandial greater than 200 mg/dL).
Postoperative nausea and vomiting . postoperative pulmonary complications including atelectasis, pneumonia and respiratory failureSerum insulin level in picomoles per litre (pmol/l) 30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia serum insulin level (pmol/l) 30 min before and 30 min after surgery
Serum cortisol level in micrograms per decilitre (mcg/dl) 30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia serum cortisol level (mcg/dl) 30 min before and 30 min after surgery
Trial Locations
- Locations (1)
Ain Shams University
🇪🇬Cairo, Egypt