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临床试验/NCT02738567
NCT02738567Unknown不适用

Assessment of Adverse Cardiac Events Using Local Anesthesia With Adrenaline

Meir Medical Center0 个研究点目标入组 500 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
主要终点
number of participants with arrythmia

研究概览

简要总结

The use of vasopressor supplement materials to local anesthetics is commonly used in procedures in various fields of dentistry, ENT (ear, nose, and throat), Plastic Surgery, Hand surgery and gastroenterology. Epinephrine is used to constrict small blood vessels, thus reducing bleeding during a medical procedure, reducing the toxicity by reducing systemic absorption of local anesthetic, and prolonging the duration and intensity of neural blockage created by the local anesthetic.

There are descriptions in the literature of cases in which the use of lidocain and adrenaline caused adverse cardiac events such as arrhythmias, edema and increase in blood pressure during ENT and dentistry procedures. As far as we know there has never been a systematic examination of the incidence and severity of arrhythmias during procedures with local anesthesia.

The purpose of the study:

  1. To examine the prevalence and types of arrhythmias in patients undergoing a medical procedure performed under local anesthesia
  2. Examine whether adding adrenaline to the local anesthetics affects the incidence of arrhythmia Determining the prevalence and types of arrhythmia will help determine the need for monitoring and type of monitoring required during procedures under local anesthesia.

The patients:

500 patients undergoing surgery or a medical procedure in which a local anesthetic is used at Meir Hospital. Patients with a medical history of known cardiac arrhythmia will not be included.

Methods:

Patients will undergo the medical procedure prescribed for them, using local anesthesia with or without adrenaline, at the discretion of the surgeon, in accordance with the usual routine being applied nowadays. The amount and type of anesthesia used will be registered. In addition to the routine monitoring that is currently performed (blood pressure cuff and non-invasive blood oxygen saturation) a continuous ECG monitoring device will be connected prior to the beginning of the surgical procedure, until the patient is discharged from the recovery room. The ECG monitoring results will be analyzed to detect arrhythmia. Side effects being reported by patients (palpitations, dizziness, fainting, CPR {cardiopulmonary resuscitation} ) will be recorded. In cases that an arrhythmia is detected, the type of arrhythmia and the presence of clinical symptoms will be investigated.

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 undergoing surgery or a medical procedure in which a local anesthetic is used at Meir Hospital.

排除标准

  • Patients with a medical history of known cardiac arrhythmia will not be included.

结局指标

主要结局

number of participants with arrythmia

时间窗: day 1

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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