Clinical trial NCT06773689: The Role of Near-infrared Spectroscopy Measurements in Determining İntraoperative Blood Loss in Cancer Surgery
Official title: The Role of Cerebral and Peripheral Near-infrared Spectroscopy in Determining Intraoperative Blood Loss in Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Near-Infrared Spectroscopy
Cancer Surgery
Lead sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sixty-five adult patients (aged 18-75 years) with American Society of Anesthesiologists (ASA) physical status I-III who were scheduled for major cancer surgery in the General Surgery, Urology, and Obstetrics and Gynecology departments

Brief summary: Major cancer surgeries often involve significant intraoperative blood loss and require transfusion. Conventional markers, such as hemoglobin (Hb) and hematocrit (Hct), provide limited insight into tissue oxygenation and transfusion thresholds. Near-infrared spectroscopy (NIRS) is a non-invasive approach for monitoring regional tissue oxygen saturation and guiding transfusion decisions. This study aimed to evaluate the role of cerebral (cSO₂) and peripheral (pSO₂) NIRS measurements in identifying intraoperative blood loss and determining transfusion thresholds during major cancer surgeries.

Detailed description: This prospective observational study included 65 patients aged 18-75 years who underwent major cancer surgery. cSO₂ and pSO₂ were monitored at three time points: baseline (T1), pre-transfusion or significant blood loss (T2), and the end of surgery (T3).Hemodynamic parameters, acid-base status, hemoglobin levels, estimated blood loss, and transfusion volumes were recorded.Patients were divided into transfused (group 1) and non-transfused (group 2) cohorts. Statistical analyses included t-tests, Mann-Whitney U tests, and receiver operating characteristic (ROC) analysis.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-III
* major cancer surgery in the General Surgery, Urology, and Obstetrics and Gynecology departments

Exclusion Criteria:

* carotid artery stenosis
* recent myocardial infarction
* history of cerebrovascular events
* prior neck surgery,
* cervical disc herniation
* spinal cord injury,
* sudden vision loss,
* deep vein thrombosis,
* refusal to participate.

Primary outcomes:
measure: cerebral NIRS measurements
timeFrame: T1 (Baseline): Before the start of surgery T2 (Pre-transfusion / Abundant bleeding): In the event of significant blood loss or just before transfusion T3 (At the end of surgery; assessed up to 5 minutes)
measure: peripheral NIRS measurements
timeFrame: T1 (Baseline): Before the start of surgery T2 (Pre-transfusion / Abundant bleeding): In the event of significant blood loss or just before transfusion T3 (At the end of surgery; assessed up to 5 minutes)
Secondary outcomes:
measure: Hemoglobin
timeFrame: T1 (Baseline): Before the start of surgery T2 (Pre-transfusion / Abundant bleeding): In the event of significant blood loss or just before transfusion T3 (At the end of surgery; assessed up to 5 minutes
measure: Hematocrit
timeFrame: T1 (Baseline): Before the start of surgery T2 (Pre-transfusion / Abundant bleeding): In the event of significant blood loss or just before transfusion T3 (At the end of surgery; assessed up to 5 minutes
measure: Estimated Blood Loss
timeFrame: T1 (Baseline): Before the start of surgery T2 (Pre-transfusion / Abundant bleeding): In the event of significant blood loss or just before transfusion T3 (At the end of surgery; assessed up to 5 minutes
Other outcomes:
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