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临床试验/NCT05131854
NCT05131854Unknown不适用

Incidence , Risk Factors and Outcomes of Haemodynamic Instability and Cardiac Arrest During Spine Surgery

Zagazig University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年11月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Incidence of Haemodynamic Instability during Spine Surgery

研究概览

简要总结

Risk factors for cardiac arrest during spine surgery have been well defined, including lumbar fusion, age over 65 years, obesity, cardiovascular disease, ethnicity and ASA status. Bradycardia and asystole have been described under general anaesthesia in combined surgical cohorts: Proposed mechanisms include unopposed parasympathetic activation, enhanced vasovagal response to decreased venous return, and psychiatric stressors. The investigators prospectively will review patients candidates for spine surgery to explore potential incidence, contributory factors and outcomes to unexpected transient intraoperative haemodynamic instability, arrhythmia, and cardiac arrest during spine surgery as these data are needed to aid risk stratification and improve decision making for spine care teams.

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

  • Aged more than 18
  • Gender: both.
  • ASA grade I-II (American society of anesthiologists).
  • Prepared to spine surgery under general anesthesia

排除标准

  • Ischemic heart patients
  • Hypertensive patients
  • Patients with atrial fibrillation or any previous history of attack of arrhythmias
  • Patients on B.B ( beta-blockers)
  • Chronic use of neuropsychiatric medications
  • Renal Impairment
  • Liver Dysfunction.
  • Any complications during the procedure as massive hemorrhage
  • Surgery for traumatic spinal cord

结局指标

主要结局

Incidence of Haemodynamic Instability during Spine Surgery

时间窗: allover one year

To calculate Incidence of Haemodynamic Instability during Spine Surgery

outcomes of Haemodynamic Instability during Spine Surgery

时间窗: allover one year

To calculate the rate of mortality of Haemodynamic Instability during Spine Surgery

Incidence of cardiac arrest during Spine Surgery

时间窗: allover one year

To calculate Incidence of cardiac arrest during Spine Surgery

Risk factors of cardiac arrest during Spine Surgery

时间窗: allover one year

To analyze risk factors of cardiac arrest during Spine Surgery

outcomes of Cardiac Arrest during Spine Surgery

时间窗: allover one year

To calculate the rate of mortality of cardiac arrest during Spine Surgery

Risk factors of Haemodynamic Instability during Spine Surgery

时间窗: allover one year

To analyze risk factors of Haemodynamic Instability during Spine Surgery

次要结局

未报告次要终点

研究者

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

Essamedin Mamdouh Negm

principal investigator

Zagazig University

研究点 (1)

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