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临床试验/NCT07450014
NCT07450014招募中不适用

The Effect of Preoperative Anxiety Level on Vasovagal Events During Spinal Anesthesia and the Incidence of Vasovagal Events

Sanliurfa Mehmet Akif Inan Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2026年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,500
试验地点
1
主要终点
Incidence of Vasovagal Events During Spinal Anesthesia

研究概览

简要总结

To determine the anxiety levels of patients undergoing spinal anesthesia before surgery and to observe the effect of this anxiety level on vasovagal events that may be observed during spinal anesthesia.

详细描述

Spinal anesthesia is a frequently used anesthesia method in clinics because it creates a rapid and effective sensory and motor block by injecting a low dose of local anesthetic into the subarachnoid space. Its success rate is over 90%. Vasovagal syncope (neurocardiogenic syncope; sudden loss of consciousness due to decreased blood flow to the brain and arterial blood pressure through neural mechanisms as a result of vasodilation. In this condition, cardiac arrest may occur following the development of bradycardia and hypotension. It is assumed that syncope may be related to anxiety, emotional triggers, or pain, and that this triggers the parasympathetic pathway leading to hypotension and bradycardia. Psychogenic, intense sympathetic blockade is considered among the causes of vasovagal syncope during spinal or epidural anesthesia. The main aim of this research is to determine the anxiety levels of patients undergoing spinal anesthesia before surgery and to investigate the effect of this anxiety level on vasovagal events that may be observed during spinal anesthesia.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Soicety of Anesthesiologists (ASA) I-II Patients
  • 18-65 years patients

排除标准

  • Patients who did not wish to participate in the study voluntarily
  • patients for whom spinal anesthesia is contraindicated
  • Pregnant and breastfeeding women
  • ASA III-IV-V patients

研究组 & 干预措施

Spinal Anesthesia Patients

Adult patients undergoing elective surgery under spinal anesthesia. Preoperative anxiety levels will be assessed and the incidence of vasovagal events during spinal anesthesia will be recorded.

结局指标

主要结局

Incidence of Vasovagal Events During Spinal Anesthesia

时间窗: T1: in the preoperative period, T2: during anesthesia, T3: in the first 5 minutes after anesthesia

Vasovagal event is defined as the occurence of braycardia(heart rate\<50) or hypotension(systolic blood pressure decrease \>%30 from baseline symptoms such as nausea, dizziness, transient loss of conciouness.

次要结局

  • Preoperative anxiety scale(Preoperative period)
  • non-invasive mean arterial pressure(T1: Preoperative, T2:Immediately after anesthesia, T3: 5 minutes after anesthesia, T4:When the surgery is over)
  • Heart Rate(T1: Preoperative, T2:Immediately after anesthesia, T3: 5 minutes after anesthesia, T4:When the surgery is over)

研究者

发起方
Sanliurfa Mehmet Akif Inan Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

VEYSİ YAZAR

Specialist Of Anesthesiology And Reanimation

Sanliurfa Mehmet Akif Inan Education and Research Hospital

研究点 (1)

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