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.
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.
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.
- Conditions
- Septoplasty Surgeries
- 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 group | Role | What 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.
Incidence of TCR
Defined as a decrease in heart rate >20% from baseline during surgery
Measured: 3 hours from induction
Secondary outcomes (2)
Magnitude of heart rate reduction
reduction of heart rate less than 50 beats/min
Measured: 3 hours from induction
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.
- First posted23 Feb 2026
- Study start1 May 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Septoplasty SurgeriesStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatmaelzahraa Omar Mahmoud Bahr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatmaelzahraa Omar Mahmoud Bahr, Fayoum University Hospital
- Investigators
- Mohamed A Hamed, Professor, Principal investigator, Fayoum University HospitalFatmaelzahraa O Bahr, Lecture, Study director, Fayoum University HospitalMohamed E Khalil, Lecture, Study chair, Fayoum University Hospital
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 27812317Ulusoy 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
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
- Impact of "Cold Dissection" vs. "Electrocautery" on the Incidence of TCR During Septoplasty
- ClinicalTrials.gov ID
- NCT07425834
- Acronym / sponsor ID
- TCR / R803
- Conditions
- Septoplasty Surgeries
- Keywords
- trigeminal cardiac reflex, Cold Dissection, Electrocautery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fatmaelzahraa Omar Mahmoud BahrUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 23 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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Randomization and Group Allocation Patients will be randomly allocated into two groups using computer-generated randomization:
Key inclusion criteria (3 listed)
- Age 18-60 years.
- Indicated for primary septoplasty.
- American Society of Anesthesiologists (ASA) physical status I-II.
Key exclusion criteria (4 listed)
- 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.
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
Incidence of TCR
Time frame: 3 hours from induction
Defined as a decrease in heart rate >20% from baseline during surgery
2 secondary outcomes
Magnitude of heart rate reduction
Time frame: 3 hours from induction
Intraoperative hypotension or arrhythmias
Time frame: 3 hours from induction
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 36524908Ulusoy 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.
- Individual participant dataSharing planned: No
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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 A Hamed, Professor principal investigator
Fayoum University Hospital
Fatmaelzahraa O Bahr, Lecture study director
Fayoum University Hospital
Mohamed E 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 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.