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Clinical Trials in Turkey / NCT07719439
Active, not recruiting Observational

Heart Rate Variability and Early Cytokine Profile in Pediatric Adenotonsillectomy

NCT07719439 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-07-01
Last updated
2026-07-22

Condition(s) studied

Heart Rate MonitoringVagal BradycardiaAdenotonsillar HypertrophyTonsillitis; HypertrophicAdverse Cardiac EventRespiratory ComplicationAnesthesia

Study 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.

Eligibility

Sex
ALL
Min age
5 Years
Max age
9 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Duzce University Düzce Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07719439 on ClinicalTrials.gov ↗ ← All trials in Turkey