跳至主要内容
临床试验/NCT05198648
NCT05198648已完成不适用

Trigeminal Nerve Cardiac Reflex During Resection of Cerebellopontine Angle Tumors and Postoperative Myocardial Injury: a Prospective Cohort Study

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 476 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
476
试验地点
1
主要终点
The incidence of postoperative myocardial injury

研究概览

简要总结

Myocardial injury after noncardiac surgery is significantly related to postoperative 30-day mortality. Trigeminal cardiac reflex is one of the main causes of perioperative cardiac emergency. Therefore, the investigators' aim is to test the hypothesis that trigeminal cardiac reflex associates postoperative myocardial damage in participants undergoing skull base tumor surgery. The investigators will observe the association between trigeminal cardiac reflex and myocardial injury by measuring the concentration of plasma high sensitivity cardiac troponin (hs-cTnT) in participants after skull base tumor surgery.

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 elective skull base tumor surgery.
  • Age ≥ 18 years old.
  • ASA class I to III.
  • All those who sign the informed consent form.

排除标准

  • Patients with severe heart disease (including patients with preoperative heart rate < 50 beats / min, severe arrhythmias, such as premature beats, paroxysmal supraventricular tachycardia, atrial flutter or fibrillation, patients with myocardial ischemia < 6 months, heart failure, myocarditis, pericarditis or cardiomyopathy).
  • Patients unable to complete preoperative cardiac assessment.
  • Patients with chronic kidney disease.

结局指标

主要结局

The incidence of postoperative myocardial injury

时间窗: Postoperative 1 day.

the elevation of plasma high sensitivity cardiac troponin I (hs-cTnI) caused by myocardial ischemia or injury (exclude other causes such as sepsis, pulmonary embolism, atrial fibrillation, etc). The blood samples before and within 24 hours after operation will be collected and measured by Roche's fourth generation hs-cTnI. It is commonly defined as an elevation as any value above the 99th percentile upper reference limit for each specific troponin I assay

次要结局

  • The duration time of trigeminal cardiac reflex during skull base tumor surgery.(The whole skull base tumor surgery procedure.)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuming Peng

Deputy chief of Department of Anesthesiology

Beijing Tiantan Hospital

研究点 (1)

Loading locations...

相似试验