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临床试验/NCT05160207
NCT05160207已完成不适用

Tracheal Intubation-induced Decrease in Heart Rate as an Indicator for Intraoperative Bradycardia During Microlaryngoscopy -a Prospective Observational Trial

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Intraoperative decrease of the heart rate

研究概览

简要总结

This prospective observational study aims to determine, if an tracheal intubation-related decrease in heart rate is associated with intraoperative reflex bradycardia in patients undergoing microlaryngoscopy (MLS) in general anesthesia.

详细描述

Small studies and case series reported precipitous bradycardia or even asystole due to reflex vagal activity during tracheal intubation and/or laryngoscopy attributable to a so called laryngocardiac reflex (reflex bradycardia); however, larger systematic trials are still lacking. For the purpose of MLS, ENT surgeons frequently apply suspension laryngoscopy (Kleinsasser laryngoscope) in order to visualize the glottis and to enable surgery. Severe bradycardia has been reported during MLS that has been suspected to be induced by reflex vagal activity possibly promoted by the superior laryngeal nerve.

It is still unknown, which patients are at risk for relevant intraoperative bradycardia and moreover, which patients might benefit from preemptive measures such as prophylactic application of positive chronotropic drugs like atropine sulfate, epinephrine or glycopyrrolate. Predictive factors for MLS-induced intraoperative bradycardia have not systematically been investigated yet.

In particularly, it is unknown, if patients that present with a preoperative tracheal intubation-related decrease in heart rate have a predisposition for intraoperative reflex bradycardia during MLS.

This prospective observational study aims to determine, if an tracheal intubation-related decrease in heart rate is associated with intraoperative reflex bradycardia in patients undergoing microlaryngoscopy (MLS) in general anesthesia. Moreover, if we find a positive association, we further aim to determine the predictive value of intubation-relatd bradycardia.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients requiring general anesthesia with tracheal intubation for elective MLS

排除标准

  • Pregnant or breastfeeding women
  • Confirmed indications for awake fiberoptic intubation
  • Planned endotracheal intubation without deep anesthesia or neuromuscular blocking agents (e.g. awake videolaryngoscopy)
  • Patients at risk for pulmonary aspiration who qualify for rapid sequence induction
  • Cardiac pacemaker
  • Atrial fibrillation
  • Denial of consent

结局指标

主要结局

Intraoperative decrease of the heart rate

时间窗: 1 hour

Continuous intraoperative ECG heart rate measurement (sample rate 1000 hz)

次要结局

  • Adverse cardiocirulatory events(1 hour)
  • PACU stay(8 hours)
  • Application of atropine sulfate(1 hour)
  • Application of positive inotropic drugs(1 hour)
  • Hypotension(1 hour)
  • Cardiac arrhythmias(1 hour)
  • Application of catecholamines or vasoactive drugs(1 hour)
  • Intraoperative asystolia(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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