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Analgesia Nociception Index Monitoring in Trigeminal Cardiac Reflex During Nasal Septoplasty

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07435870
Acronym
ANI
Enrollment
90
Registered
2026-02-27
Start date
2026-04-01
Completion date
2027-05-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ENT Disease

Keywords

Analgesia Nociception Index, Trigeminal Cardiac Reflex, Septoplasty

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.

Detailed description

Nasal septoplasty is among the most frequently performed otorhinolaryngological procedures and is generally regarded as safe. However, it may occasionally be complicated by autonomic reflexes, most notably the trigeminal cardiac reflex (TCR) . The TCR is a brainstem reflex triggered by stimulation of the trigeminal nerve or its branches, resulting in sudden parasympathetic activation manifested as bradycardia, hypotension, arrhythmias, or even cardiac arrest. Clinically, TCR is typically defined as a decrease in heart rate exceeding 20% from baseline following trigeminal stimulation . The nasal septum is richly innervated by branches of the trigeminal nerve, particularly in the posterior septal region and near the sphenopalatine area. Surgical manipulation during septoplasty, including mucoperichondrial flap elevation, septal correction, and spur removal, can therefore precipitate TCR. Reported incidence rates of TCR during nasal surgery vary widely in the literature, ranging from approximately 15% to 25%, depending on surgical technique, anesthetic depth, and patient-related factors. Although most episodes are transient and reversible, unanticipated bradycardia can lead to hemodynamic instability and interruption of surgery, underscoring the importance of early detection and prevention . Traditionally, anesthesiologists rely on conventional hemodynamic parameters such as heart rate and blood pressure to assess autonomic responses and anesthetic adequacy . However, these parameters represent relatively late manifestations of vagal activation. By the time a significant decrease in heart rate is observed, the trigeminal cardiac reflex has already occurred. Therefore, a monitoring modality capable of detecting early changes in autonomic balance before overt bradycardia develops would be of considerable clinical value . The Analgesia Nociception Index (ANI) is a non-invasive monitoring tool derived from heart rate variability analysis, reflecting the balance between sympathetic and parasympathetic activity. ANI primarily reflects parasympathetic tone, with values ranging from 0 to 100. Higher values indicate parasympathetic predominance, whereas lower values suggest sympathetic activation or inadequate analgesia. Maintaining ANI values within a target range (commonly 50-70) has been proposed as a strategy to optimize intraoperative analgesia and autonomic stability. Given that TCR is mediated by sudden parasympathetic overactivity, continuous ANI monitoring may provide an early warning signal of impending reflex activation . A sudden drop in ANI could theoretically precede the hemodynamic manifestations of TCR, allowing timely anesthetic or surgical interventions to prevent or attenuate the reflex. Despite its growing use in anesthesia practice, the role of ANI monitoring in predicting and preventing TCR during nasal septoplasty has not been adequately studied. Data analysis will be carried out using SPSS (IBM SPSS Statistics) and/or R. Continuous variables will be expressed as mean ± standard deviation (SD) when normally distributed, or as median with interquartile range for nonnormally distributed data. Categorical variables will be summarized as frequencies and percentages. A p-value of less than 0.05 (two-tailed) will be considered statistically significant. Group comparisons will be conducted using: Independent samples t-test for normally distributed continuous data, Mann-Whitney U test for skewed continuous data, Chi-square test or Fisher's exact test for categorical data

Interventions

None listed

Sponsors

Fayoum University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Age 18-60 years. * American society of anesthesiologist physical status I-II * Indicated for primary septoplasty.

Exclusion criteria

* Known cardiac arrhythmias or conduction disorders. * Use of beta-blockers or antiarrhythmic medications. * Previous nasal surgery and Combined nasal procedures. * Inability to obtain reliable Analgesia Nociception Index readings.

Design outcomes

Primary

MeasureTime frameDescription
Primary Outcome - Incidence of trigeminal cardiac reflex3 hoursDefined as a decrease in heart rate \>20% from baseline during surgery.

Secondary

MeasureTime frameDescription
Time interval between Analgesia Nociception Index drop and subsequent heart rate decrease (early warning window).3 hoursTime in minutes between occurrence of Analgesia Nociception Index drop and subsequent heart rate decrease
Total intraoperative opioid consumption.3 hours.The amount in milligram of opioid consumption.
Incidence of hypotension or arrhythmias.3 hoursDecrease mean arterial pressure less than 60mmgh or occurrence of tachycardia or bradycardia.

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORMohamed Ahmed Hamed, Professor

Fayoum University Hospital

STUDY_DIRECTORFatmaelzahraa Omar Bahr, Lecture

Fayoum University Hospital

STUDY_CHAIRMohamed Eid Khalil, Lecture

Fayoum University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026