How blood sugar control affects brain oxygen levels and recovery during urologic surgery
Effects of Intraoperative Near-Infrared Spectroscopy and Postoperative Recovery on Glycemic Control Levels in Patients With Diabetes Mellitus: A Prospective Study
Ege University · NCT07491185
This will see if long-term blood sugar control affects brain oxygen levels during anesthesia and recovery afterward in adults having elective urologic operations, including people with and without diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ege University (other) |
| Locations | 1 site (Izmir) |
| Trial ID | NCT07491185 on ClinicalTrials.gov |
What this trial studies
This prospective observational study groups adults undergoing elective urologic surgery by preoperative HbA1c into four categories, including non-diabetic controls. Intraoperative monitoring will include standard hemodynamic parameters and continuous bilateral regional cerebral oxygen saturation measured with near-infrared spectroscopy (NIRS). Researchers will compare intraoperative cerebral oxygenation and postoperative recovery scores across glycemic control groups. Analyses will explore whether higher HbA1c is associated with impaired cerebral perfusion during anesthesia and differences in early postoperative recovery.
Who should consider this trial
Good fit: Adults (age ≥18) scheduled for elective urologic surgery under general anesthesia with a preoperative HbA1c available and ASA physical status I–III, including both diabetic and non-diabetic patients, are eligible.
Not a fit: Patients having emergency surgery, ASA >III, with prior cerebrovascular or neurological disease, or those who cannot provide reliable NIRS data are unlikely to benefit from the findings.
Why it matters
Potential benefit: If a link is found, better long-term blood sugar control could help reduce intraoperative brain hypoxia and improve postoperative recovery strategies for surgical patients with diabetes.
How similar studies have performed: NIRS monitoring has been used successfully in other surgical populations to detect cerebral desaturation, but direct evidence linking chronic glycemic control to intraoperative cerebral oxygenation is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Patients scheduled for elective urologic surgery under general anesthesia * ASA physical status I-III * Patients with diabetes mellitus or non-diabetic control patients * Availability of preoperative HbA1c measurement * Written informed consent obtained Exclusion Criteria: * Age \<18 years * ASA physical status \>III * Emergency surgery * History of cerebrovascular disease or neurological disorder * Previous brain or neurological surgery * Inability to communicate or refusal to participate * Intraoperative hemodynamic instability * Inadequate NIRS monitoring data
Where this trial is running
Izmir
- Ege University Faculty of Medicine Hospital — Izmir, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: NURSEN KARACA, MD — Ege University
- Study coordinator: Nursen Karaca, MD
- Email: dr.nursenkaraca@hotmail.com
- Phone: +902323902142
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Glycemic Control, Cerebral Oxygenation, Anesthesia, Near-Infrared Spectroscopy, Postoperative Recovery