The Role of Near-infrared Spectroscopy Measurements in Determining İntraoperative Blood Loss in Cancer Surgery

NCT06773689 | Completed

• 1 other identifier: 2015-01/01
• Study Type: observational
• Target: 65
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Near-Infrared Spectroscopy; Cancer Surgery

Outcome Measures

Primary Outcomes (2)

• cerebral NIRS measurements

  Near-infrared spectroscopy

  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)

• peripheral NIRS measurements

  Near-infrared spectroscopy

  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 (3)

• Hemoglobin

  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

• Hematocrit

  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

• Estimated Blood Loss

  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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 14, 2025
• Study Start: January 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: September 30, 2015
• Last Updated: January 14, 2025

Record last verified: 2025-01