Fayoum University Hospital
Al Fayyum, 63514, Egypt
NCT Number: NCT07425834
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.
Trial opening soon.
Get Notified18 year–60 year
All sexes
Observational
Al Fayyum, 63514, Egypt
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 hours from induction
Defined as a decrease in heart rate >20% from baseline during surgery
Time frame: 3 hours from induction
reduction of heart rate less than 50 beats/min
Time frame: 3 hours from induction
decrease mean blood pressure less than 60mmgh
Contact information is provided by the study sponsor or research team.
Fatmaelzahraa O Bahr, Lecture
CONTACT
Mohamed A Hamed, Professor
CONTACT
00201010509736 ext. +201118560065
Fatmaelzahraa Omar Mahmoud Bahr
Other
Impact of "Cold Dissection" vs. "Electrocautery" on the Incidence of TCR During Septoplasty
Acronym: TCR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07407751
Septoplasty Surgeries
View Trial DetailsNCT07304206
Confusion, Delirium
Malatya, Turkey (Türkiye)
View Trial DetailsNCT06957262
Airway Obstruction, Athletic Performance
View Trial Details