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.
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.
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 group | Role | What they receive |
|---|---|---|
| Group A (Control Group | Standard 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.
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)
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
Total intraoperative opioid consumption.
The amount in milligram of opioid consumption.
Measured: 3 hours.
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.
- First posted27 Feb 2026
- Study start1 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ENT DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatmaelzahraa Omar Mahmoud Bahr, Fayoum University Hospital
- Investigators
- Mohamed Ahmed Hamed, Professor, Principal investigator, Fayoum University HospitalFatmaelzahraa Omar Bahr, Lecture, Study director, Fayoum University HospitalMohamed Eid Khalil, Lecture, Study chair, Fayoum University Hospital
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 27812317Lunardi 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 41440971Dadgarnia 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Analgesia Nociception Index (ANI) Monitoring in Predicting and Preventing Trigeminal Cardiac Reflex During Nasal Septoplasty
- ClinicalTrials.gov ID
- NCT07435870
- Acronym / sponsor ID
- ANI / R804
- Conditions
- ENT Disease
- Keywords
- Analgesia Nociception Index, Trigeminal Cardiac Reflex, Septoplasty
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Control Group | – | –Standard 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients scheduled for elective nasal septoplasty under general anesthesia will be enrolled.
Key inclusion criteria (3 listed)
- Age 18-60 years.
- American society of anesthesiologist physical status I-II
- Indicated for primary septoplasty.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Outcome - Incidence of trigeminal cardiac reflex
Time frame: 3 hours
Defined as a decrease in heart rate >20% from baseline during surgery.
3 secondary outcomes
Time interval between Analgesia Nociception Index drop and subsequent heart rate decrease (early warning window).
Time frame: 3 hours
Total intraoperative opioid consumption.
Time frame: 3 hours.
Incidence of hypotension or arrhythmias.
Time frame: 3 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Results publication: PubMed 27812317Lapi 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.
- Results publication: PubMed 41440971Lunardi 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.
- Results publication: PubMed 24303423Dadgarnia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
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.