- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07054411
- Original Trial
Hemoglobin Monitoring in Scoliosis Surgery
March 31, 2026 updated by: Erhan Ozyurt
Hemoglobin Monitoring in Scoliosis Surgery: Comparison of Non-invasive and Invasive Methods
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
53
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Antalya, Turkey (Türkiye), 07000
- University of Health Sciences Antalya Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients who apply to our hospital's orthopedic clinics to undergo elective scoliosis surgery.
Description
Inclusion Criteria:
- Preoperative hemoglobin ≥ 9 g/dL
- ASA I - III
Exclusion Criteria:
- Patients with hematological disease,
- Uncorrected preoperative anemia (preoperative hemoglobin < 9 g/dL)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Scoliosis patients
Include patients who will undergo elective scoliosis surgery under general anesthesia.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Hemoglobin (SpHb)
Time Frame: Before the anesthesia induction
|
Total Hemoglobin will be recorded from the monitor
|
Before the anesthesia induction
|
|
Total Hemoglobin (SpHb)
Time Frame: 1 hour after the anesthesia induction
|
Total Hemoglobin will be recorded from the monitor
|
1 hour after the anesthesia induction
|
|
Total Hemoglobin (SpHb)
Time Frame: 2 hours after the anesthesia induction
|
Total Hemoglobin will be recorded from the monitor
|
2 hours after the anesthesia induction
|
|
Total Hemoglobin (SpHb)
Time Frame: 3 hours after the anesthesia induction
|
Total Hemoglobin will be recorded from the monitor
|
3 hours after the anesthesia induction
|
|
Total Hemoglobin (SpHb)
Time Frame: Through operation completion, an average of 4 hours
|
Total Hemoglobin will be recorded from the monitor
|
Through operation completion, an average of 4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2025
Primary Completion (Actual)
March 15, 2026
Study Completion (Actual)
March 31, 2026
Study Registration Dates
First Submitted
June 27, 2025
First Submitted That Met QC Criteria
June 27, 2025
First Posted (Actual)
July 8, 2025
Study Record Updates
Last Update Posted (Actual)
April 1, 2026
Last Update Submitted That Met QC Criteria
March 31, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEMAL01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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