This prospective, single-center, observational cohort study is designed to evaluate the relationship between intraoperative submental tissue oxygenation, microvascular reactivity, and arterial lactate levels during major surgical procedures performed under general anesthesia.
Major surgery is defined as procedures associated with a substantial risk of blood loss and/or tissue perfusion impairment, requiring invasive arterial blood pressure monitoring and hourly arterial blood gas analysis. Eligible surgical categories include major abdominal, neurosurgical, and major orthopedic procedures. Adult patients aged 18 years and older who meet the inclusion criteria will be enrolled.
All anesthetic and surgical management will be conducted according to standard clinical practice. The study protocol will not influence clinical decision-making. Hemodynamic management, fluid therapy, blood product transfusion, and ventilatory settings will be determined solely by the responsible anesthesia and surgical teams.
Intraoperative tissue oxygenation will be continuously monitored using near-infrared spectroscopy (NIRS). A NIRS sensor will be placed on the submental region, just inferior to the mandibular border and near the midline, after appropriate skin preparation. The sensor will be secured to minimize ambient light interference and motion artifacts. Baseline submental tissue oxygenation will be defined as the values obtained during a hemodynamically stable period of at least five minutes following anesthesia induction, without active surgical stimulation or significant fluctuations in mean arterial pressure.
Submental NIRS measurements will be recorded at 15-minute intervals throughout the intraoperative period, and hourly average and minimum values will be documented. A NIRS desaturation event will be defined as a decrease of 10% or more from baseline tissue oxygenation lasting for at least three minutes.
Microvascular reactivity will be assessed using the vascular occlusion test (VOT) applied to the thenar eminence of the non-dominant hand. A NIRS probe will be positioned on the thenar region following skin preparation. Transient arterial occlusion will be achieved using a non-invasive blood pressure cuff placed on the same upper extremity. The reoxygenation slope (ReO₂ slope) obtained during the reperfusion phase will be recorded as an indicator of microvascular reactivity. VOT measurements will be performed hourly during surgery and, whenever possible, synchronized with arterial blood gas sampling.
Arterial blood gas samples will be obtained hourly through an existing arterial catheter as part of routine intraoperative monitoring. Recorded parameters will include arterial lactate concentration, pH, base excess, hemoglobin, and hematocrit. Arterial lactate level will be considered the primary outcome measure of the study.
Intraoperative clinical data, including mean arterial pressure, vasopressor use, estimated blood loss, administered crystalloid and colloid fluids, and blood product transfusions, will be recorded on an hourly basis. For patients receiving blood transfusions, the indication for transfusion and timing of administration will be documented.
The intraoperative observation period will extend from anesthesia induction to the completion of surgery. All collected data will be analyzed to assess associations between submental tissue oxygenation, microvascular reactivity parameters, and arterial lactate levels over time. The study aims to explore whether non-invasive monitoring of tissue oxygenation and microvascular function may provide early insight into intraoperative tissue perfusion disturbances during major surgery.
