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ENT DiseaseANINCT07435870

Analgesia Nociception Index Monitoring in Trigeminal Cardiac Reflex During Nasal Septoplasty

An observational study of ENT Disease, run by Fayoum University Hospital at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
ENT Disease
How many people
90 participants
Where
1 siteEgypt
Study dates
1 Apr 2026to 1 May 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Adult patients scheduled for elective nasal septoplasty under general anesthesia will be enrolled.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Fayoum univeristy hospital

    Al Fayyum, Faiyum Governorate, 63514

Other trials in Egypt

About this study

Official title: Utility of Analgesia Nociception Index (ANI) Monitoring in Predicting and Preventing 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.

Read the 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

Conditions
ENT Disease
Keywords
Analgesia Nociception Index, Trigeminal Cardiac Reflex, Septoplasty
Medical subject headings
Otorhinolaryngologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07435870
Study groupRoleWhat they receive
Group A (Control GroupStandard monitoring including heart rate, non-invasive blood pressure, oxygen saturation, and bispectral index (BIS).
Group B (ANI Group)Standard monitoring plus continuous ANI monitoring, with intraoperative analgesia adjusted to maintain Analgesia Nociception Index ( ANI) values between 50 and 70

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome - Incidence of trigeminal cardiac reflex

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

    Measured: 3 hours

Secondary outcomes (3)
  1. Time interval between Analgesia Nociception Index drop and subsequent heart rate decrease (early warning window).

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

    Measured: 3 hours

  2. Total intraoperative opioid consumption.

    The amount in milligram of opioid consumption.

    Measured: 3 hours.

  3. Incidence of hypotension or arrhythmias.

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

    Measured: 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start1 Apr 2026
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07435870
Sponsor's protocol ID
R804
Acronym
ANI
Status last verified
Mar 2026
First submitted
21 Feb 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lapi D, Scuri R, Colantuoni A. Trigeminal Cardiac Reflex and Cerebral Blood Flow Regulation. Front Neurosci. 2016 Oct 20;10:470. doi: 10.3389/fnins.2016.00470. eCollection 2016.

    PubMed 27812317
  • Lunardi G, Giombi F, Pace GM, Cerasuolo M, Spriano G, Malvezzi L. Measuring Nasal Airway Resistance to Personalize Surgery for Nasal Obstruction in OSA Patients. J Pers Med. 2025 Dec 8;15(12):608. doi: 10.3390/jpm15120608.

    PubMed 41440971
  • Dadgarnia MH, Baradaranfar MH, Mazidi M, Azimi Meibodi SM. Assessment of Septoplasty Effectiveness using Acoustic Rhinometry and Rhinomanometry. Iran J Otorhinolaryngol. 2013 Spring;25(71):71-8.

    PubMed 24303423

Questions about this trial

What is this clinical trial studying?

An observational study of ENT Disease, run by Fayoum University Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome - Incidence of trigeminal cardiac reflex (time frame: 3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07435870, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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