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临床试验/NCT06573957
NCT06573957已完成不适用

Comparison of the Effects of Intravenous Administration of Dexmedetomidine 0.5 μg/kg Body Weight With Intravenous Lidocaine 1.5 mg/kg Body Weight on Blood Pressure and Heart Rate Response During Laryngoscopy and Endotracheal Intubation

Universitas Padjadjaran1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年5月29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
状态
已完成
入组人数
42
试验地点
1
主要终点
Heart rate

研究概览

简要总结

Endotracheal intubation is considered a definitive therapy and the gold standard for airway management. However, this procedure carries several risks, including sudden increases in blood pressure and heart rate. These spikes in blood pressure and heart rate can be tolerated by healthy individuals, but for patients with cerebrovascular and cardiovascular risk factors, they can be extremely dangerous and even life-threatening. Various techniques and drug choices can be employed to prevent the hemodynamic surges associated with endotracheal intubation, including the use of anesthetic drugs from the α2-adrenergic agonist and amide classes. One of the α2-adrenergic agonists commonly used to prevent hemodynamic surges during endotracheal intubation is dexmedetomidine, while one of the amide drugs frequently used for this purpose is lidocaine.

详细描述

Dexmedetomidine works very selectively on noradrenergic receptors distributed both within and outside the central nervous system, particularly in the pons and medulla. Presynaptic stimulation of α2 receptors can reduce the release of norepinephrine and the activation of postsynaptic α2 receptors. Lidocaine works by inhibiting sodium channels within cells, preventing the occurrence of action potentials and the transmission of impulses along nerves. Lidocaine also acts by blocking calcium and potassium channels as well as N-methyl-D-aspartate (NMDA) receptors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-59 years.
  • Patients scheduled for oral intubation.
  • Physical status ASA I and II (American Society of Anesthesiologists).
  • Patients with Mallampati classification I-II.

排除标准

  • History of allergy to the drugs that will be used.
  • Pregnant patients.
  • Patients taking medications that affect blood pressure and heart rate, such as vasodilators, adrenergic blockers, antiarrhythmics, and cardiac stimulants.
  • Patients with arrhythmias, AV block, liver disorders, hypertension, and hypoalbuminemia.
  • Patients who have been given opioids within the last 24 hours.
  • Patients with predicted intubation difficulties.

研究组 & 干预措施

Dexmedetomidine

Active Comparator

Twenty-one patients are administered dexmedetomidine at a dose of 0.5 µg/kg body weight 10 minutes before induction, then receive general anesthesia induction with intravenous propofol 2 mg/kg body weight and intravenous atracurium 0.5 mg/kg body weight. Positive pressure ventilation is then applied for 3 minutes using a ventilator in volume control mode with a tidal volume of 6-8 mL/kg body weight, a respiratory rate of 12 breaths per minute, and PEEP 5. Oxygen at 3 liters, air at 3 liters, and sevoflurane at 2 vol% are set.

干预措施: Dexmedetomidine (Drug)

Lidocaine

Active Comparator

Twenty-one patients receive general anesthesia induction with intravenous propofol 2 mg/kg body weight and intravenous atracurium 0.5 mg/kg body weight. Positive pressure ventilation is then applied for 3 minutes using a ventilator in volume control mode with a tidal volume of 6-8 mL/kg body weight, a respiratory rate of 12 breaths per minute, and PEEP 5. Oxygen at 3 liters, air at 3 liters, and sevoflurane at 2 vol% are set, followed by lidocaine at 1.5 mg/kg body weight in a 5cc syringe 90 seconds before intubation.

干预措施: Lidocain (Drug)

结局指标

主要结局

Heart rate

时间窗: Right after endotracheal intubation until 5 minutes after endotracheal intubation

Diastolic blood pressure

时间窗: Right after endotracheal intubation until 5 minutes after endotracheal intubation

Systolic blood pressure

时间窗: Right after endotracheal intubation until 5 minutes after endotracheal intubation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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