Type 2 Diabetes Mellitus (T2DM), Thoracic Surgery
Conditions
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)
Interventions
DRUGTIVA
Anesthesia will be maintained by total intravenous anesthesia with propofol infusion (4 to 12 mcg/kg/min) and fentanyl infusion (1-2mcg /kg/hour) that will be stopped 30 min before the end of the operation ,The heart rate and blood pressure will be maintained within the range of ±20% of the baseline
Anesthesia will be maintained with inhaled isoflurane, Iso-MAC from (0.7 to 1.4%)(Hawkley, Preston, and Maani 2018) and fentanyl infusion (1-2mcg /kg/hour) that will be stopped 30 min before the end of the operation ,The heart rate and blood pressure will be maintained within the range of ±20% of the baseline
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 30 - 70 years * Sex: Both sexes * Patients with type 2 diabetes mellitus controlled with oral hypoglycemic drugs * Patients with ASA classification II,III * Duration of surgery (≥2 h)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 failure |
Countries
Egypt
Outcome results
None listed