Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07435870

Analgesia Nociception Index Monitoring in Trigeminal Cardiac Reflex During Nasal Septoplasty

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Primary Outcome - Incidence of trigeminal cardiac reflex

    Time frame: 3 hours

    Defined as a decrease in heart rate >20% from baseline during surgery.

Secondary outcomes

  1. Time interval between Analgesia Nociception Index drop and subsequent heart rate decrease (early warning window).

    Time frame: 3 hours

    Time in minutes between occurrence of Analgesia Nociception Index drop and subsequent heart rate decrease

  2. Total intraoperative opioid consumption.

    Time frame: 3 hours.

    The amount in milligram of opioid consumption.

  3. Incidence of hypotension or arrhythmias.

    Time frame: 3 hours

    Decrease mean arterial pressure less than 60mmgh or occurrence of tachycardia or bradycardia.

Study contacts

Contact information is provided by the study sponsor or research team.

Fatmaelzahraa Omar Bahr, lecture

CONTACT

[email protected]

00201097356769

Mohmed Ahmed Hamed, professor

CONTACT

[email protected]

0020101050999736

Sponsors and collaborators

Lead sponsor

Fayoum University Hospital

Other

Registry information

Official study title

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

Acronym: ANI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Mar 4, 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.

Published trials that share one or more normalized conditions with this study.