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RecruitingNCT07491185

Effect of Glycemic Control on Intraoperative NIRS and Postoperative Recovery in Diabetic Patients

Effects of Intraoperative Near-Infrared Spectroscopy and Postoperative Recovery on Glycemic Control Levels in Patients With Diabetes Mellitus: A Prospective Study

Status
Recruiting
Phase
Study type
Observational
Enrollment
80 (estimated)
Sponsor
Ege University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Timeline

Start date
2025-11-01
Primary completion
2026-09-01
Completion
2027-03-01
First posted
2026-03-24
Last updated
2026-03-24

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07491185. Inclusion in this directory is not an endorsement.