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临床试验/NCT04284150
NCT04284150Unknown不适用

Treatment of Supraventricular Tachycardia in Patients With Non-cardiac Surgery by Dexmedetomidine During the Perioperative Period

Lianyungang Hospital Affiliated Bengbu Medical College0 个研究点目标入组 60 人开始时间: 2020年2月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
midazolam treat supraventricular tachycardia

研究概览

简要总结

Supraventricular tachycardia (SVT) is a common arrhythmia in the perioperative period, which is associated with adverse stimulus such as cardiovascular risk factors, emotional tension, hypoxia, CO2 accumulation, hypokalemia, atropine and pain. To treat perioperative SVT, in addition to massage the vagus nerve, the use of antiarrhythmic drugs and other internal medicine classic methods, the cardiovascular protection of anesthetic drugs is also a common adjuvant treatment. Dexmedetomidine which is widely used as an adjuvant to general anesthesia, can excite α2 receptor to produce sedation, analgesia, inhibition of sympathetic activity, stabilization of hemodynamics and other effects.

Dexmedetomidine is approved by FDA for use in operating room anesthesia and intensive care unit sedation in adults. Although dexmedetomidine is not approved for the treatment of arrhythmias, a growing number of evidences indicated dexmedetomidine can serve as a potential treatment for arrhythmias in perioperative patients. Liu et al. confirmed that dexmedetomidine can reduce ventricular rate and improve atrial fibrillation in cardiac surgery patient. Ji et al. showed that dexmedetomidine anesthesia can be effective in lowering cardiovascular and cerebrovascular complications and mortality in patients one year after coronary bypass surgery. A number of retrospective analyses of pediatric patients undergoing cardiac surgery have shown the incidence of perioperative SVT in patients treated with dexmedetomidine sedation is significantly decreased, which prompts that dexmedetomidine has the potential prevention and treatment for tachyarrhythmia. Therefore, the investigators selected dexmedetomidine for sedation in patients with perioperative SVT to explore the effect for treating SVT via its sedation and mechanism of anti-sympatheticon in this study.

详细描述

Forty patients with SVT of both sexes, aged 35-61 yr, of American Society of Anesthesiologists physical status Ⅰ-Ⅱ, who undergo elective surgery, were randomly divided into two groups (n=30) including dexmedetomidine group (group D) and midazolam group (group M). For comparison of the efficacy of dexmedetomidine and midazolam in the treatment of SVT, the following needs to be done. The patients calm down for 5-10 minutes after getting into the operating room, group D and group M started as a continuous infusion with dexmedetomidine 0.5µg/kg or midazolam 0.06mg/kg using a micro-pump for 10 minutes. The alarm/sedation (OAA/S) score, heart rate (HR), mean arterial pressure (MAP), pulse oxygen saturation (SpO2) and occurrence of SVT were recorded before the infusion (T0), 5 minutes after the infusion (T1), at the end of the infusion (T2), 5 minutes after the end of the infusion (T3) and 10 minutes after the end of the infusion (T4). In two groups, miniature electrocardiograph was used to monitor the frequency domain index of heart rate variability (HRV) in 5 minutes at each time point including normalized low frequency power (LFnorm), normalized high frequency power (HFnorm) and the balance ratio of sympathetic to vagal tone (LF/HF).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 61 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with supraventricular tachycardia

排除标准

  • Patients who suffered from significant hemodynamic instability, and can not receive dexmedetomidine and midazolam, were thus excluded from the study.
  • Patients with other types of arrhythmia, not SVT, abnormal liver and kidney function and anaesthesia-related drug allergy, were excluded from the study.

研究组 & 干预措施

dexmedetomidine or Midazola treat supraventricular tachycardia

Experimental

Comparison of efficacy of dexmedetomidine and Midazolam in the treatment of SVT

干预措施: Dexmedetomidine; Midazolam; (Drug)

结局指标

主要结局

midazolam treat supraventricular tachycardia

时间窗: through study completion, up to 6 months

effective rate of midazolam on supraventricular tachycardia

dexmedetomidine treat supraventricular tachycardia

时间窗: through study completion, up to 6 months

effective rate of dexmedetomidine on supraventricular tachycardia

Comparison of efficacy of dexmedetomidine and midazolam in the treatment of SVT

时间窗: through study completion, up to 6 months

occurrence of SVT recorded before the infusion dexmedetomidine and midazolam (T0), 5 minutes after the infusion (T1), at the end of the infusion (T2), 5 minutes after the end of the infusion (T3) and 10 minutes after the end of the infusion (T4) in two groups

次要结局

  • mean arterial pressure (MAP)(through study completion, up to 6 months)
  • normalized low frequency power(through study completion, up to 6 months)
  • normalized high frequency power(through study completion, up to 6 months)
  • alarm/sedation (OAA/S) score(through study completion, up to 6 months)
  • heart rate (HR)(through study completion, up to 6 months)
  • pulse oxygen saturation (SpO2)(through study completion, up to 6 months)
  • the balance ratio of sympathetic to vagal tone(through study completion, up to 6 months)

研究者

发起方
Lianyungang Hospital Affiliated Bengbu Medical College
申办方类型
Other
责任方
Sponsor

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