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NCT Number: NCT07719439

Heart Rate Variability and Early Cytokine Profile in Pediatric Adenotonsillectomy

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.

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This study is active but is not currently recruiting participants.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. HRV parameters' effect on perioperative cardiac events

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

    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.

Secondary outcomes

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

    Time frame: 1 day

    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.

  2. Association of HRV and PAED score after extubation

    Time frame: 30 minute after extubation

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

  3. Relationship of COLDS score and perioperative adverse events

    Time frame: 30 minutes

    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.

Sponsors and collaborators

Lead sponsor

Duzce University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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