Skip to content

Cold Dissection vs Electrocautry on TCR in Septoplasty

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07425834
Acronym
TCR
Enrollment
120
Registered
2026-02-23
Start date
2026-05-01
Completion date
2027-03-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septoplasty Surgeries

Keywords

trigeminal cardiac reflex, Cold Dissection, Electrocautery

Brief 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.

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.

Interventions

None listed

Sponsors

Fatmaelzahraa Omar Mahmoud Bahr
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of TCR3 hours from inductionDefined as a decrease in heart rate \>20% from baseline during surgery

Secondary

MeasureTime frameDescription
Magnitude of heart rate reduction3 hours from inductionreduction of heart rate less than 50 beats/min
Intraoperative hypotension or arrhythmias3 hours from inductiondecrease mean blood pressure less than 60mmgh

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORMohamed A Hamed, Professor

Fayoum University Hospital

STUDY_DIRECTORFatmaelzahraa O Bahr, Lecture

Fayoum University Hospital

STUDY_CHAIRMohamed E Khalil, Lecture

Fayoum University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026