AzTrials
AzTrials

Septoplasty SurgeriesTCRNCT07425834

Cold Dissection vs Electrocautry on TCR in Septoplasty

An observational study of Septoplasty Surgeries, run by Fatmaelzahraa Omar Mahmoud Bahr 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 address these gaps by comparing the incidence of TCR during septoplasty performed using cold dissection versus electrocautery, while also incorporating a novel assessment of surgical force. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Septoplasty Surgeries
How many people
120 participants
Where
1 siteEgypt
Study dates
1 May 2026to 1 Mar 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
  • Healthy volunteers accepted
  • Adult

Study population: Randomization and Group Allocation Patients will be randomly allocated into two groups using computer-generated randomization:

Who may be able to join

  • Age 18-60 years.
  • Indicated for primary septoplasty.
  • American Society of Anesthesiologists (ASA) physical status I-II.

Who cannot join

  • History of cardiac arrhythmias or conduction abnormalities.
  • Use of beta-blockers, calcium channel blockers, or antiarrhythmic drugs Previous nasal surgery.
  • Combined nasal procedures.
  • Intraoperative complications requiring deviation from the assigned technique.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Fayoum University Hospital

    Al Fayyum, 63514

Other trials in Egypt

About this study

Official title: Impact of "Cold Dissection" vs. "Electrocautery" on the Incidence of TCR During Septoplasty

This study aims to address these gaps by comparing the incidence of TCR during septoplasty performed using cold dissection versus electrocautery, while also incorporating a novel assessment of surgical force.

Read the detailed description

Septoplasty is one of the most commonly performed otorhinolaryngological procedures and is generally considered safe . However, it may be associated with rare but potentially serious autonomic reflexes, most notably the trigeminal cardiac reflex (TCR) . The TCR is a brainstem reflex characterized by sudden parasympathetic activation resulting in bradycardia, hypotension, arrhythmias, or even asystole following stimulation of the trigeminal nerve or its branches. Clinically, TCR is usually defined as a sudden reduction in heart rate exceeding 20% from baseline during trigeminal nerve stimulation . The trigeminal nerve provides rich sensory innervation to the nasal septum, particularly in the posterior septal region and near the sphenopalatine area. Surgical manipulation in these areas during septoplasty can trigger TCR, especially when the stimulus is intense or prolonged . While TCR has been extensively reported in neurosurgical, maxillofacial, and skull base procedures, its occurrence during nasal surgery is increasingly recognized but remains underreported and underinvestigated .

Several factors are believed to influence the incidence and severity of TCR, including the type, intensity, and duration of trigeminal stimulation. Both mechanical stimulation, such as traction, pressure, or fracture of bone and cartilage, and thermal stimulation, such as electrocautery, can activate trigeminal afferents . Experimental and clinical observations suggest that thermal stimulation may produce a stronger and more sustained trigeminal response compared to mechanical manipulation alone, potentially leading to a higher incidence of TCR . Despite the widespread use of electrocautery for dissection and hemostasis during septoplasty, there is limited evidence directly comparing its impact on TCR incidence with that of cold steel dissection techniques. Cold dissection relies primarily on mechanical separation using scissors, chisels, and elevators, avoiding thermal injury to surrounding tissues and neural endings. Whether this difference in stimulus modality translates into a clinically significant difference in TCR incidence has not been systematically evaluatedData 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 non- normally 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.

Keywords
trigeminal cardiac reflex, Cold Dissection, Electrocautery

What participants receive

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

Study groups in NCT07425834
Study groupRoleWhat they receive
Group C (Cold Dissection Group)Septoplasty performed using cold steel instruments only (scissors, elevators, chisels) for flap elevation and spur removal, with avoidance of electrocautery near the septal base.
Group E (Electrocautery Group)Septoplasty performed using monopolar or bipolar electrocautery for dissection near the septal base and posterior septum.

What is being measured

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

  1. Incidence of TCR

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

    Measured: 3 hours from induction

Secondary outcomes (2)
  1. Magnitude of heart rate reduction

    reduction of heart rate less than 50 beats/min

    Measured: 3 hours from induction

  2. Intraoperative hypotension or arrhythmias

    decrease mean blood pressure less than 60mmgh

    Measured: 3 hours from induction

Timeline

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

  1. First posted23 Feb 2026
  2. Study start1 May 2026
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Mar 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
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07425834
Sponsor's protocol ID
R803
Acronym
TCR
Status last verified
Feb 2026
First submitted
14 Feb 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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
  • Ulusoy S, Bayar Muluk N, Scadding GK, Passali GS, Dilber M, Gevaert P, Passali D, Resuli AS, Van Gerven L, Kalogjera L, Prokopakis E, Rombaux P, Hellings P, Cingi C. The intranasal trigeminal system: roles in rhinitis (allergic and non-allergic). Eur Rev Med Pharmacol Sci. 2022 Dec;26(2 Suppl):25-37. doi: 10.26355/eurrev_202212_30479.

    PubMed 36524908

Questions about this trial

What is this clinical trial studying?

An observational study of Septoplasty Surgeries, run by Fatmaelzahraa Omar Mahmoud Bahr 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?

Incidence of TCR (time frame: 3 hours from induction). 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 NCT07425834, which also lists 2 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.

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