Heart Rate Variability and Early Cytokine Profile in Pediatric Adenotonsillectomy | NCT07719439

NCT07719439

Overview

NCT ID: NCT07719439
Lead Sponsor: Duzce UniversityOTHER
Official Title: Association of Short-Term Heart Rate Variability and Early Inflammatory Cytokine Profile With Perioperative Respiratory and Cardiac Adverse Events in Pediatric Adenotonsillectomy: A Prospective Observational Cohort Study
Brief Summary: This prospective observational cohort study will assess whether perioperative short-term heart rate variability (HRV) indices and early inflammatory cytokine levels are associated with respiratory and cardiac adverse events in children undergoing elective adenoidectomy, tonsillectomy, or adenotonsillectomy under general anesthesia. HRV will be recorded noninvasively from 30 minutes before surgery until discharge from the post-anesthesia care unit. Serum cytokines will be measured from 3 mL of residual blood obtained after induction of anesthesia. The study aims to identify perioperative physiologic markers associated with a lower or higher risk of adverse events, thereby supporting safer anesthetic planning.
Conditions

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Age 5-9 years;

elective adenoidectomy, tonsillectomy, or adenotonsillectomy operation

ASA physical status I-II;

surgery planned under general anesthesia;

able to undergo standard endotracheal intubation and standard anesthetic protocol

-; no dermatologic or cardiac barrier to preoperative Holter monitoring;

written informed consent provided by parent/legal guardian.

Exclusion Criteria:

ASA physical status III or higher; congenital heart disease, arrhythmia, or cardiac conduction disorder;

known neurologic disease (e.g., epilepsy or cerebral palsy);

psychiatric diagnosis;

chronic inflammatory or immune-system disease;

acute infection within 2 weeks before surgery

regular steroid, immunosuppressive, or anti-inflammatory medication use;

endocrine disease such as uncontrolled thyroid disease;

preoperative hemodynamic instability;

major unexpected intraoperative complication or ICU requirement;

intraoperative atropine, lidocaine, beta-blocker, or epinephrine use;

history of prematurity or syndromic disease;

parent/legal guardian declines consent.