Hemoglobin Monitoring in Scoliosis Surgery

NCT07054411 | Completed

• 1 other identifier: CEMAL01
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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

Keywords

scoliosis; hemoglobin monitoring

Outcome Measures

Primary Outcomes (5)

• Total Hemoglobin (SpHb)

  Total Hemoglobin will be recorded from the monitor

  Before the anesthesia induction

• Total Hemoglobin (SpHb)

  Total Hemoglobin will be recorded from the monitor

  1 hour after the anesthesia induction

• Total Hemoglobin (SpHb)

  Total Hemoglobin will be recorded from the monitor

  2 hours after the anesthesia induction

• Total Hemoglobin (SpHb)

  Total Hemoglobin will be recorded from the monitor

  3 hours after the anesthesia induction

• Total Hemoglobin (SpHb)

  Total Hemoglobin will be recorded from the monitor

  Through operation completion, an average of 4 hours

Study Arms (1)

Scoliosis patients

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

Device: Radical-7 Pulse CO-Oximeter

Interventions

Radical-7 Pulse CO-Oximeter 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.

Also known as: Hemogram samples

Scoliosis patients

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who apply to our hospital's orthopedic clinics to undergo elective scoliosis surgery.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Erhan Ozyurt: lead

Study Sites (1)

University of Health Sciences Antalya Training and Research Hospital

Antalya, 07000, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 30895376 BACKGROUND

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, MD

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: July 1, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 31, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

TU (1)