Effect of Glycemic Control on Intraoperative NIRS and Postoperative Recovery in Diabetic Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEge University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age <18 years
ASA physical status >III
Emergency surgery
History of cerebrovascular disease or neurological disorder
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 4 trial groupsGroup A: Control
Group B: HbA1c 6-7
Group C: HbA1c 7-8
Group D: HbA1c >8
Trial outcomes
Primary outcomes
1
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.
Time frame
Intraoperative period (from anesthesia induction to extubation)Sponsors and contacts
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Source ClinicalTrials.gov