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临床试验/NCT07435870
NCT07435870进行中(未招募)不适用

Utility of Analgesia Nociception Index (ANI) Monitoring in Predicting and Preventing Trigeminal Cardiac Reflex During Nasal Septoplasty

Fayoum University Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年4月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
90
试验地点
1
主要终点
Primary Outcome - Incidence of trigeminal cardiac reflex

研究概览

简要总结

This study aims to evaluate the utility of Analgesia Nociception Index (ANI) monitoring as a predictive and preventive tool for TCR during septoplasty. By comparing standard anesthetic monitoring with ANI-guided analgesia, this research seeks to determine whether maintaining optimal autonomic balance can reduce the incidence of trigeminal cardiac reflex (TCR) and improve intraoperative cardiovascular stability.

详细描述

Nasal septoplasty is among the most frequently performed otorhinolaryngological procedures and is generally regarded as safe. However, it may occasionally be complicated by autonomic reflexes, most notably the trigeminal cardiac reflex (TCR) . The TCR is a brainstem reflex triggered by stimulation of the trigeminal nerve or its branches, resulting in sudden parasympathetic activation manifested as bradycardia, hypotension, arrhythmias, or even cardiac arrest. Clinically, TCR is typically defined as a decrease in heart rate exceeding 20% from baseline following trigeminal stimulation .

The nasal septum is richly innervated by branches of the trigeminal nerve, particularly in the posterior septal region and near the sphenopalatine area. Surgical manipulation during septoplasty, including mucoperichondrial flap elevation, septal correction, and spur removal, can therefore precipitate TCR. Reported incidence rates of TCR during nasal surgery vary widely in the literature, ranging from approximately 15% to 25%, depending on surgical technique, anesthetic depth, and patient-related factors. Although most episodes are transient and reversible, unanticipated bradycardia can lead to hemodynamic instability and interruption of surgery, underscoring the importance of early detection and prevention .

Traditionally, anesthesiologists rely on conventional hemodynamic parameters such as heart rate and blood pressure to assess autonomic responses and anesthetic adequacy . However, these parameters represent relatively late manifestations of vagal activation. By the time a significant decrease in heart rate is observed, the trigeminal cardiac reflex has already occurred. Therefore, a monitoring modality capable of detecting early changes in autonomic balance before overt bradycardia develops would be of considerable clinical value .

The Analgesia Nociception Index (ANI) is a non-invasive monitoring tool derived from heart rate variability analysis, reflecting the balance between sympathetic and parasympathetic activity. ANI primarily reflects parasympathetic tone, with values ranging from 0 to 100. Higher values indicate parasympathetic predominance, whereas lower values suggest sympathetic activation or inadequate analgesia. Maintaining ANI values within a target range (commonly 50-70) has been proposed as a strategy to optimize intraoperative analgesia and autonomic stability.

Given that TCR is mediated by sudden parasympathetic overactivity, continuous ANI monitoring may provide an early warning signal of impending reflex activation . A sudden drop in ANI could theoretically precede the hemodynamic manifestations of TCR, allowing timely anesthetic or surgical interventions to prevent or attenuate the reflex. Despite its growing use in anesthesia practice, the role of ANI monitoring in predicting and preventing TCR during nasal septoplasty has not been adequately studied.

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.
  • American society of anesthesiologist physical status I-II
  • Indicated for primary septoplasty.

排除标准

  • Known cardiac arrhythmias or conduction disorders.
  • Use of beta-blockers or antiarrhythmic medications.
  • Previous nasal surgery and Combined nasal procedures.
  • Inability to obtain reliable Analgesia Nociception Index readings.

研究组 & 干预措施

Group A (Control Group

Standard monitoring including heart rate, non-invasive blood pressure, oxygen saturation, and bispectral index (BIS).

Group B (ANI Group)

Standard monitoring plus continuous ANI monitoring, with intraoperative analgesia adjusted to maintain Analgesia Nociception Index ( ANI) values between 50 and 70

结局指标

主要结局

Primary Outcome - Incidence of trigeminal cardiac reflex

时间窗: 3 hours

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

次要结局

  • Time interval between Analgesia Nociception Index drop and subsequent heart rate decrease (early warning window).(3 hours)
  • Total intraoperative opioid consumption.(3 hours.)
  • Incidence of hypotension or arrhythmias.(3 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatmaelzahraa Omar Mahmoud Bahr

lecture

Fayoum University Hospital

研究点 (1)

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