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临床试验/NCT07425834
NCT07425834进行中(未招募)不适用

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

Fatmaelzahraa Omar Mahmoud Bahr1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年5月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
120
试验地点
1
主要终点
Incidence of TCR

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

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.

结局指标

主要结局

Incidence of TCR

时间窗: 3 hours from induction

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

次要结局

  • Magnitude of heart rate reduction(3 hours from induction)
  • Intraoperative hypotension or arrhythmias(3 hours from induction)

研究者

发起方
Fatmaelzahraa Omar Mahmoud Bahr
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fatmaelzahraa Omar Mahmoud Bahr

Lecture

Fayoum University Hospital

研究点 (1)

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