Evaluation of Cerebral Oxygenation During Orthopedic Surgeries Performed in the Beach Chair Position Under General Anesthesia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAkdeniz University

About this trial

The goal of this observational study is to determine the correlation between cerebral oxygenation values measured by near-infrared spectroscopy (NIRS) and other routine monitoring parameters in patients placed in the semi-sitting position.

The primary questions investigated are :

Do NIRS values correlate with heart rate, invasive mean arterial pressure, and end-tidal carbon dioxide?

Do NIRS values reflect changes observed in arterial blood gas analysis?

Are cerebral perfusion-related parameters associated with patients' comorbidities such as diabetes, obesity, and hypertension?

Researchers will compare routine noninvasive monitoring (heart rate, blood pressure, peripheral oxygen saturation) with invasive arterial monitoring and NIRS to assess whether NIRS provides additional information for evaluating cerebral perfusion.

Participants will be monitored for:

Heart rate

Invasive mean arterial pressure

End-tidal carbon dioxide

Arterial blood gas changes

Cerebral oxygenation with NIRS

Patients' comorbidities (e.g., diabetes, obesity, hypertension) will also be recorded, and their association with perfusion-related parameters will be analyzed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scheduled for orthopedic surgery in the semi-sitting position

ASA physical status I-III

Voluntary participation with informed consent

Disqualifiers

Patients younger than 18 years

Patients who do not provide consent

History of cerebral ischemia

History of head trauma

Trial population

Adult patients (18 years and older, ASA I-III) undergoing orthopedic surgery in the semi-sitting position, monitored for cerebral oxygenation (NIRS), invasive arterial pressure, and routine intraoperative parameters.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Near-Infrared Spectroscopy (NIRS) Monitoring

    Diagnostic test

    Cerebral oxygenation will be monitored using NIRS in addition to standard intraoperative monitoring (heart rate, invasive arterial pressure, end-tidal CO₂, and blood gas analysis).

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Orthopedic Surgery Patients in Semi-sitting Position1 intervention

Trial outcomes

Primary outcomes

1

Correlation Between Cerebral Oxygenation (rSO₂) Measured by NIRS and Systemic Oxygenation

The correlation between intraoperative cerebral oxygenation (regional cerebral oxygen saturation, rSO₂) (%)-measured non-invasively using near-infrared spectroscopy (NIRS) -and simultaneous systemic oxygenation assessed using arterial blood gas analysis, including: Arterial pH, PaO₂ (mmHg) and PaCO₂ (mmHg)

Time frame
From pre-induction baseline through post-induction and positional measurements, followed by repeated assessments every 30 minutes until the end of surgery.
2

Correlation Between Cerebral Oxygenation (rSO₂) Measured by NIRS and Hemodynamic Parameters (Heart Rate and Blood Pressure)

The correlation between intraoperative cerebral oxygenation (regional cerebral oxygen saturation, rSO₂) (%)-measured non-invasively using near-infrared spectroscopy (NIRS) -and systemic hemodynamic parameters. Systemic hemodynamic parameters will include: 1. Heart rate (beats per minute), monitored continuously via electrocardiography (ECG) 2. Noninvasive mean arterial pressure (mmHg), measured using an automated oscillometric device 3. Invasive mean arterial pressure (mmHg), obtained via an arterial catheter

Time frame
From pre-induction baseline through post-induction and positional measurements, followed by repeated assessments every 30 minutes until the end of surgery.

Secondary outcomes

1

Association of Preoperatively Documented Hypertension with Intraoperative Low Cerebral Oxygenation (rSO₂) Measured by Near-Infrared Spectroscopy

The associations between preoperatively diagnosed hypertension with the occurrence of intraoperative reductions in regional cerebral oxygen saturation (rSO₂), defined as values falling below the normal range (60-75%).

Time frame
Preoperative period for comorbidity assessment and intraoperative period for cerebral oxygenation measurements (from pre-induction baseline to the end of surgery.
2

Association of Preoperatively Documented Diabetes Mellitus with Intraoperative Low Cerebral Oxygenation (rSO₂) Measured by Near-Infrared Spectroscopy

The associations between preoperatively diagnosed diabetes mellitus, and the occurrence of intraoperative reductions in regional cerebral oxygen saturation (rSO₂), defined as values falling below the normal range (60-75%).

Time frame
Preoperative period for comorbidity assessment and intraoperative period for cerebral oxygenation measurements (from pre-induction baseline to the end of surgery.
3

Association of Preoperatively Documented Obesity with Intraoperative Low Cerebral Oxygenation (rSO₂) Measured by Near-Infrared Spectroscopy

The associations between preoperative obesity-defined as a body mass index (BMI) greater than 30 kg/m²-and the occurrence of intraoperative reductions in regional cerebral oxygen saturation (rSO₂), defined as values falling below the normal range (60-75%).

Time frame
Preoperative period for comorbidity assessment and intraoperative period for cerebral oxygenation measurements (from pre-induction baseline to the end of surgery.

Other outcomes

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