Heart Rate Variability and Early Cytokine Profile in Pediatric Adenotonsillectomy

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anesthesia; Respiratory Complication; Heart Rate Monitoring; Adenotonsillar Hypertrophy; Vagal Bradycardia; Adverse Cardiac Event; Tonsillitis; Hypertrophic

Detailed Description

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 (Estimated): 76

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Düzce, Turkey (Türkiye), 81620
    • Duzce University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

5-9 years, elective adenoidectomy, tonsillectomy, or adenotonsillectomy operation

• ASA physical status I-II;
• Surgery planned under general anesthesia;

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day. Until discharge from the PACU (same day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	30 minutes

Collaborators and Investigators

• Sponsor: Duzce University
• Investigators: Principal Investigator: Sultan Baran Erkul, PhD, Duzce University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: July 17, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Pathological Conditions, Anatomical; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Pharyngitis; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Hypertrophy; Tonsillitis
• Other Study ID Numbers: 2026/158; Duzce University (DÜBAP) (Other Identifier: Duzce University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No