Actively Recruiting
Effects of Intraoperative Near-Infrared Spectroscopy and Postoperative Recovery on Glycemic Control Levels in Patients With Diabetes Mellitus: A Prospective Study
Led by Ege University · Updated on 2026-03-24
80
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how different levels of blood sugar control affect brain oxygen levels during surgery and recovery afterward in people with diabetes. This observational study focuses on patients undergoing planned urologic surgery under general anesthesia, dividing them into groups based on their HbA1c levels to study the link between long-term blood sugar control and brain oxygen saturation. Participants will be grouped as non-diabetic or diabetic with varying HbA1c ranges: 6-7%, 7-8%, and above 8%. During surgery, their brain oxygen levels will be continuously monitored using near-infrared spectroscopy (NIRS), a non-invasive method, alongside standard heart and blood pressure measurements. The study aims to understand if poor blood sugar control worsens cerebral oxygenation during anesthesia and how it relates to recovery. Participants will have their brain oxygen saturation tracked from anesthesia start to end, with assessments of recovery after surgery. Researchers will collect preoperative HbA1c data and monitor vital signs throughout the procedure. The study will measure changes in regional cerebral oxygen saturation and explore postoperative recovery differences by blood sugar control level. Participation involves standard monitoring during surgery with no additional interventions, and informed consent is required.
CONDITIONS
Brief Title
Effect of Glycemic Control on Intraoperative NIRS and Postoperative Recovery in Diabetic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Scheduled for elective urologic surgery under general anesthesia
- ASA physical status I to III
- Diagnosis of diabetes mellitus or non-diabetic control status
- Availability of preoperative HbA1c measurement
- Written informed consent obtained
You will not qualify if you...
- Age under 18 years
- ASA physical status greater than 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 near-infrared spectroscopy monitoring data
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week before surgery
Participants undergo preoperative assessment including measurement of HbA1c to determine glycemic control group assignment.
1 preoperative visit (in-person)
Duration - Duration of surgery (intraoperative period)
Participants are continuously monitored intraoperatively with near-infrared spectroscopy to assess cerebral oxygen saturation during surgery under general anesthesia.
Monitoring during 1 surgical procedure
Duration - Up to hospital discharge
Participants are observed postoperatively to evaluate recovery parameters in relation to glycemic control levels.
1 to 2 postoperative visits depending on recovery
Trial Site Locations
Total: 1 location
1
Ege University Faculty of Medicine Hospital
Izmir, Turkey (Türkiye), 35100
Actively Recruiting
Research Team
N
Nursen Karaca, MD
I
Işık Alper, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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