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| ID | Type | Description | Link |
|---|---|---|---|
| 25-10.2T/45 | Other Identifier | Ege University Medical Research Ethics Committee |
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This prospective observational study aims to evaluate the effect of glycemic control level on intraoperative cerebral oxygenation measured by near-infrared spectroscopy (NIRS) and postoperative recovery in patients with diabetes mellitus undergoing elective urologic surgery under general anesthesia.
Patients will be grouped according to HbA1c levels to assess the relationship between long-term glycemic control and intraoperative regional cerebral oxygen saturation, hemodynamic parameters, and postoperative recovery scores.
Diabetes mellitus is associated with increased perioperative morbidity and mortality, particularly in patients with poor long-term glycemic control. Elevated HbA1c levels may impair microcirculation and tissue oxygenation, which can affect cerebral perfusion during general anesthesia. Near-infrared spectroscopy (NIRS) is a non-invasive monitoring technique that allows continuous measurement of regional cerebral oxygen saturation and may help detect intraoperative hypoperfusion.
This prospective observational study is designed to investigate the relationship between glycemic control level and intraoperative cerebral oxygenation as well as postoperative recovery parameters in patients undergoing elective urologic surgery under general anesthesia. Patients will be divided into four groups according to preoperative HbA1c levels, including non-diabetic patients and diabetic patients with different levels of glycemic control.
Intraoperative monitoring will include standard hemodynamic parameters and bilateral regional cerebral oxygen saturation measured with near-infrared spectroscopy. The primary objective of the study is to determine whether poor glycemic control is associated with impaired cerebral oxygenation during anesthesia. Secondary objectives include evaluation of postoperative recovery parameters in relation to glycemic control level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Non-diabetic patients | ||
| HbA1c 6-7 | Diabetic patients with HbA1c between 6% and 7% | ||
| HbA1c 7-8 | Diabetic patients with HbA1c between 7% and 8% | ||
| HbA1c >8 | Diabetic patients with HbA1c greater than 8% |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Regional Cerebral Oxygen Saturation (rSO2) | Regional cerebral oxygen saturation measured intraoperatively using near-infrared spectroscopy and compared between groups according to HbA1c level. | Intraoperative period (from anesthesia induction to extubation) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients scheduled for elective urologic surgery under general anesthesia at a single tertiary university hospital will be included. The study population consists of patients with diabetes mellitus with different levels of glycemic control and non-diabetic control patients. Participants will be grouped according to preoperative HbA1c levels.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nursen Karaca, MD | Contact | +902323902142 | 2142 | dr.nursenkaraca@hotmail.com |
| Işık Alper, Professor | Contact | +902323902140 | 2140 | i.alper@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| NURSEN KARACA, MD | Ege University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University Faculty of Medicine Hospital | Recruiting | Izmir | 35100 | Turkey (Türkiye) |
Individual participant data will not be shared due to institutional regulations and privacy restrictions.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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