Effect of Glycemic Control on Intraoperative NIRS and Postoperative Recovery in Diabetic Patients
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Glycemic Control, Cerebral Oxygenation, Anesthesia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Intraoperative Near-Infrared Spectroscopy and Postoperative Recovery on Glycemic Control Levels in Patients With Diabetes Mellitus: A Prospective Study
Overview
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.
Primary outcome measures
- Change in Regional Cerebral Oxygen Saturation (rSO2) [Time frame: Intraoperative period (from anesthesia induction to extubation)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Ege University Faculty of Medicine Hospital — Izmir
Identifiers
NCT: NCT07491185 · 25-10.2T/45 · 25-10.2T/45