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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07491185
Acronym
NIRS-DM
Enrollment
80
Registered
2026-03-24
Start date
2025-11-01
Completion date
2027-03-01
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Cerebral Oxygenation, Diabetes Mellitus, Glycemic Control

Keywords

Diabetes Mellitus, Glycemic Control, Near-Infrared Spectroscopy, Postoperative Recovery

Brief 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.

Interventions

None listed

Sponsors

Ege University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Regional Cerebral Oxygen Saturation (rSO2)Intraoperative period (from anesthesia induction to extubation)Regional cerebral oxygen saturation measured intraoperatively using near-infrared spectroscopy and compared between groups according to HbA1c level.

Countries

Turkey (Türkiye)

Contacts

CONTACTNursen Karaca, MD
dr.nursenkaraca@hotmail.com+902323902142
CONTACTIşık Alper, Professor
i.alper@yahoo.com+902323902140
PRINCIPAL_INVESTIGATORNURSEN KARACA, MD

Ege University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026