Heart Rate Variability and Early Cytokine Profile in Pediatric Adenotonsillectomy

N/AActive Not RecruitingNCT07719439

Duzce University76 enrolled

Overview

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.

Eligible children aged 5 to 9 years with ASA physical status I-II who are scheduled for elective adenoidectomy, tonsillectomy, or adenotonsillectomy will be enrolled consecutively after parental written informed consent. Standard clinical care will not be altered. HRV will be obtained using Holter/ECG monitoring and analyzed using time-domain (SDNN, RMSSD) and frequency-domain (LF, HF, LF/HF) measures. Standard intraoperative monitoring, Bispectral Index, and routine anesthetic management will be recorded. A residual 3 mL venous blood specimen collected at 5 minutes after intubation and before incision will be processed for IL-6, IL-8, IL-1, IL-1 beta, TNF-alpha, and IL-10 by ELISA. Postoperative emergence delirium will be evaluated with the Pediatric Anesthesia Emergence Delirium scale. Perioperative respiratory and cardiac adverse events will be prospectively documented until discharge from the PACU.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Heart Rate Monitoring Vagal Bradycardia Adenotonsillar Hypertrophy

Eligibility

Sex: ALLMin age: 5 YearsMax age: 9 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

HRV parameters' effect on perioperative cardiac events

Association between perioperative HRV parameters and perioperative respiratory/cardiac adverse events. HRV measures: SDNN, RMSSD, LF, HF, and LF/HF derived from Holter/ECG recordings. Adverse events include laryngospasm, bronchospasm, apnea/hypopnea, breath-holding, hypoxemia/desaturation, stridor, severe cough, and clinically relevant cardiac events. Time Frame: From 30 minutes before surgery until discharge from the PACU, up to 1 day.

Time frame: 1 day. Until discharge from the PACU (same day)

Secondary Outcomes

Association between early serum cytokine concentrations (IL-6, IL-8, IL-1beta, TNF-alpha, IL-10) and perioperative respiratory/cardiac adverse events

Association between early serum cytokine concentrations (IL-6, IL-8, IL-1beta, TNF-alpha, IL-10) and perioperative respiratory/cardiac adverse events. Time Frame: Blood sampling at 5 minutes after intubation and before incision; adverse-event assessment until PACU discharge, up to 1 day.

Time frame: 1 day

Association of HRV and PAED score after extubation

Postoperative emergence quality assessed by the Pediatric Anesthesia Emergence Delirium (PAED) score. Time Frame: First 30 minutes after extubation in the PACU.

Time frame: 30 minute after extubation

Relationship of COLDS score and perioperative adverse events

Relationship of COLDS score, Bispectral Index values, demographic/operative variables, and anesthetic exposure with perioperative adverse events. Time Frame: Preoperative assessment through PACU discharge, up to 1 day.

Time frame: 30 minutes