Hemoglobin Monitoring in Scoliosis Surgery

NCT ID: NCT07054411

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-01-31

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.

Conditions

Scoliosis Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Scoliosis patients

Include patients who will undergo elective scoliosis surgery under general anesthesia.

Radical-7 Pulse CO-Oximeter

Intervention Type: DEVICE

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.

Interventions

Radical-7 Pulse CO-Oximeter

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.

Intervention Type: DEVICE

Other Intervention Names

Hemogram samples

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erhan Ozyurt

OTHER_GOV

Sponsor Role: lead

Responsible Party

Erhan Ozyurt

Associate Professor, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Health Sciences Antalya Training and Research Hospital

Antalya, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Erhan Ozyurt, MD

Role: CONTACT

eozyurt@hotmail.com

+905053171709

Cemal Dag, MD

Role: CONTACT

cemaldaa@gmail.com

+905346349096

Facility Contacts

Erhan Ozyurt, associate professor

Role: primary

eozyurt@hotmail.com

00902422494400 ext. 4497

References

Shabaninejad H, Ghadimi N, Sayehmiri K, Hosseinifard H, Azarfarin R, Gorji HA. Comparison of invasive and noninvasive blood hemoglobin measurement in the operating room: a systematic review and meta-analysis. J Anesth. 2019 Jun;33(3):441-453. doi: 10.1007/s00540-019-02629-1. Epub 2019 Mar 20.

Reference Type: BACKGROUND

PMID: 30895376 (View on PubMed)

Other Identifiers

CEMAL01

Identifier Type: -

Identifier Source: org_study_id