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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A will receive total inravenous anesthesia (TIVA) | Active Comparator | patients in this group will receive total intravenous anesthesia using propofol infusion after induction of anesthesia, tested variables will be measured according to the protocol | |
| Group B will receive inhalational anesthesia (IHA) | Active Comparator | patients in this group will receive inhalational anesthesia using isoflurane, tested variables will be measured according to the protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIVA | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose levels in milligrams per decilitre (mg/dl) at different time points | 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) | Immediate preoperative till 48 hours after recovery from anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Serum insulin level in picomoles per litre (pmol/l) | serum insulin level (pmol/l) 30 min before and 30 min after surgery | 30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia |
| Serum cortisol level in micrograms per decilitre (mcg/dl) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nabila M Abdelaziz, professor | Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Egypt |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
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|
| Inhalational anesthesia | Drug | 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 |
|
serum cortisol level (mcg/dl) 30 min before and 30 min after surgery |
| 30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia |
| The incidence of postoperative complications | 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 | The complications will be assessed on the first, third and seveth post-operative day |
| D004700 | Endocrine System Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |