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临床试验/NCT03731429
NCT03731429Unknown4 期

Efficiency of Intravenous Lidocaine to Reduce Coughing and the Hemodynamic Changes Associated to Tracheal Extubation

Hospital Fernandez1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2019年4月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
144
试验地点
1
主要终点
Determine the efficiency of IV lidocaine in reducing the incidence of coughing

研究概览

简要总结

Coughing during tracheal extubation can be associated to adverse effects like tachycardia, arterial hypertension (AHT), increase of intracranial pressure (ICP) and intraocular pressure (IOP), and the dehiscence of surgical wounds. In ophthalmic, head and neck, and abdominal surgery, and in several other neurosurgical interventions it is vital to prevent these effects. The incidence of laryngeal irritation due to orotracheal intubation hinders patient comfort in the immediate postoperative (POP) period and no pharmacological intervention has been yet proven to prevent it.

At the end of the surgical procedure, the depth of the anesthetic plane decreases with the concomitant suspension of the anesthetic agents. However, the patient still requires ventilatory support through the endotracheal tube (EDT). The physical stimulation of the trachea created by this foreign body leads to the activation of the sympathetic nervous system, expressed in AHT, tachycardia, and ICP. To tolerate the EDT and prevent these effects, different maneuvers have been tested such as extubating the patient in a deep anesthetic plane or administering intravenous (IV) narcotics with the entailed complications: airway (AW) obstruction and hypercapnia, and the aspiration of an unprotected AW. Progress has been made with the introduction of ultrashort acting opioids, with significant statistical results. Moreover, beta-blockers, calcium channel blockers, angiotensin converting enzyme inhibitors and dexmedetomidine have been used to decrease the hemodynamic impact associated to tracheal extubation. The use of both IV and intratracheal lidocaine in doses ranging from 1 mg/kg to 3 mg/kg, has been studied with controversial results.

In view of the above, and as lidocaine is the most commonly used low-cost drug in all operating rooms with a good safety profile when used at low doses, the purpose of this study is twofold: to assess its effects at reducing coughing and to evaluate its hemodynamic impact when administering IV 1 mg/kg prior to extubation. Then, the efficiency of reducing the incidence of sore throats after the immediate POP shall be investigated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Intervention

Experimental

Group that receives a 1 mg/kg single bolus of 2% IV lidocaine

干预措施: Lidocaine (Drug)

Placebo

Placebo Comparator

group that receives 0.9% saline solution

干预措施: Saline Solution (Drug)

结局指标

主要结局

Determine the efficiency of IV lidocaine in reducing the incidence of coughing

时间窗: From the moment the endotracheal tube is retired to 5 minutes after

Apply the Minogue scale to assess the coughing associated to tracheal extubation. Modified Minogue scale by Likert: (ordinal, 0 to 5) Grade 1: absence of coughing and muscle stiffness Grade 2: transient coughing while removing EDT Grade 3: moderate cough (3 or less coughing episodes each lasting one or two seconds) Grade 4: muscular stiffness or severe cough (4 ore more episodes lasting more tham two seconds) Grade 5: laryngospasm

Determine the efficiency of IV lidocaine in reducing the increase in heart rate (HR) associated with tracheal extubation

时间窗: From the end of anesthesia to 5 minutes after tracheal extubation (At time 0, time 2 and time 3)

Gather HR record at the time of the extubation. Difference in HR between time 0 and time 2 (discreet, bpm) Difference in HR between time 0 and time 3 (discreet, bpm)

Determine the efficiency of IV lidocaine in reducing the arterial hypertension associated with tracheal extubation

时间窗: From the end of anesthesia to 5 minutes after tracheal extubation (At time 0, time 2 and time 3)

Gather mean arterial pressure (MAP) record at the time of the extubation. Difference in MAP between anesthesia ceasing (time 0) and extubation (time 2) (continuous, mmHg) Difference in MAP between time 0 and 5 minutes after extubation (time 3) (continuous, mmHg)

次要结局

  • Record the time elapsed from the end of anesthesia and the administration of lidocaine to extubation.(Intraoperative. From the end of anesthesia (time 0) to tracheal extubation (time 2))
  • Assess immediate POP sore throat(30 minutes after extubation)

研究者

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

Santiago Ficcadenti

Principal investigator

Hospital Fernandez

研究点 (1)

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