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Studies

Observational Active not recruiting

NCT07435870 on ClinicalTrials.gov

Analgesia Nociception Index Monitoring in Trigeminal Cardiac Reflex During Nasal Septoplasty

Official title: Utility of Analgesia Nociception Index (ANI) Monitoring in Predicting and Preventing Trigeminal Cardiac Reflex During Nasal Septoplasty

  • Sponsor: Fayoum University Hospital
  • Enrollment: 90 (Estimated)
  • Study start: 2026-04-01 (Actual)
  • Primary completion: 2027-04-01 (Estimated)
  • Study completion: 2027-05-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

This study aims to evaluate the utility of Analgesia Nociception Index (ANI) monitoring as a predictive and preventive tool for TCR during septoplasty. By comparing standard anesthetic monitoring with ANI-guided analgesia, this research seeks to determine whether maintaining optimal autonomic balance can reduce the incidence of trigeminal cardiac reflex (TCR) and improve intraoperative cardiovascular stability.

Conditions

  • ENT Disease

Primary Outcome Measures

  • Primary Outcome - Incidence of trigeminal cardiac reflex (3 hours)
    Defined as a decrease in heart rate \>20% from baseline during surgery.

Countries

Egypt

Locations and Investigators

  • Fayoum univeristy hospital, Al Fayyum, Egypt

Study Officials

  • Mohamed Ahmed Hamed, Professor (Principal Investigator) — Fayoum University Hospital
  • Fatmaelzahraa Omar Bahr, Lecture (Study Director) — Fayoum University Hospital
  • Mohamed Eid Khalil, Lecture (Study Chair) — Fayoum University Hospital