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Clinical Trials/NCT07054411
NCT07054411RecruitingNot Applicable

Hemoglobin Monitoring in Scoliosis Surgery: Comparison of Non-invasive and Invasive Methods

Erhan Ozyurt1 site in 1 country53 target enrollmentStarted: July 1, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
53
Locations
1
Primary Endpoint
Total Hemoglobin (SpHb)

Study Overview

Brief Summary

The study is planned to include patients who will undergo elective scoliosis surgery under general anesthesia at the Health Sciences University Antalya Education and Research Hospital. Demographic data including age, gender, height, weight, and ASA score of the patients will be recorded before general anesthesia. ECG, oxygen saturation, and non-invasive blood pressure will be monitored while the patients are lying supine before general anesthesia. An esophageal temperature probe will be placed before being placed in the prone position. All patients will receive standard anesthesia management. After being placed in the prone position, patients will be warmed with heaters containing an air-blowing system during the operation to prevent hypothermia. Anesthesia will be maintained with total intravenous anesthesia as a controlled infusion. Rainbow sensors will be placed on the 4th fingertips of the non-dominant hand of the patients and connected to the Radical-7 Pulse CO-Oximeter device and the initial Hb value will be recorded routinely and recorded hourly during the operation. Hemogram samples will be studied in the laboratory. During the operation, every hour and at the end of the operation, SpHb value, Hb, Hct levels in hemogram will be recorded. At the end of the operation, the amount of intraoperative blood transfusion, the amount of crystalloid and colloid given, the duration of the operation, the duration of anesthesia, urine output, and the need for vasopressors will be routinely recorded. A database will be created in a computer environment from this information.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
5 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Preoperative hemoglobin ≥ 9 g/dL
  • •ASA I - III

Exclusion Criteria

  • •Patients with hematological disease,
  • •Uncorrected preoperative anemia (preoperative hemoglobin < 9 g/dL)

Outcomes

Primary Outcomes

Total Hemoglobin (SpHb)

Time Frame: Through operation completion, an average of 4 hours

Total Hemoglobin will be recorded from the monitor

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Erhan Ozyurt
Sponsor Class
Other Gov
Responsible Party
Sponsor Investigator
Principal Investigator

Erhan Ozyurt

Associate Professor, MD

Antalya Training and Research Hospital

Study Sites (1)

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