Duzce University
Düzce, 81620, Turkey (Türkiye)
NCT Number: NCT07719439
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.
This study is active but is not currently recruiting participants.
Notify Me5 year–9 year
All sexes
Observational
Düzce, 81620, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-; no dermatologic or cardiac barrier to preoperative Holter monitoring;
Exclusion criteria
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.
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.
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.
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.
Duzce University
Other
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
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