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临床试验/NCT05657028
NCT05657028招募中不适用

Intravenous Dexmedetomidine Versus Intravenous Lidocaine in Attenuating Airway Reflexes During Recovery of Thyroidectomy Patients

Ain Shams University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年9月1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
招募中
入组人数
140
试验地点
1
主要终点
compare effectiveness of Dexmedetomidine and intravenous lidocaine in attenuating cough reflex during the tracheal extubation period after thyroid surgery

研究概览

简要总结

It is widely believed that most of the patients experience a cough upon emergence from general anesthesia, due to many causes including the presence of an endotracheal tube, uncleared secretions and anesthetic gas. Cough during tracheal extubation may lead to several complications, such as hypertension, tachycardia and postoperative bleeding.

In this study the investigators are going to compare the effectiveness of intravenous Dexmedetomidine and intravenous lidocaine in attenuating the air way reflexes and coughing during recovery of thyroidectomy patients.

详细描述

Intubation and extubation process are associated with cardiovascular and various airway responses leading to tachycardia, hypertension, arrhythmia, myocardial ischemia, cough induction, bronchospasm, increased bleeding, increased intracranial and intraocular pressure. Causes possibly include the presence of an endotracheal tube, uncleared secretions, and anesthetic gas.

Furthermore, postoperative bleeding in thyroid surgery is still significant and is often associated with severe complications including cervical hematoma, reoperation and cardiac arrest.

Extubation under deep anesthesia decreases cardiovascular stimulation and reduces the incidence of coughing and straining on the tube. Intratracheal local anesthetic instillation, I.V lidocaine, short acting opioids such as fentanyl and remifentanil, esmolol, labetalol, diltiazem and verapamil have been used to attenuate these hemodynamic and respiratory responses during extubation in the past but with certain limitations.

Also "no stimulation" extubation technique avoids extubation under light anesthesia and ensures extubation only when consciousness is returned. It requires absolutely no stimulation during emergence and performing extubation only when the patient wakes up spontaneously and opens his eyes.

Recently dexmedetomidine, a potent α2-adrenoreceptor agonist has been used to facilitate extubation in surgical intensive care unit, but its role in the attenuation of hemodynamic and airway reflexes during extubation in general anesthesia is still under study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

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

  • Patients scheduled for elective thyroidectomy surgery.
  • Age: patients between 18-and 65-years old from both sexes.
  • Classified as either American Society of Anesthesiologists (ASA) class I or II.

排除标准

  • Refusal of procedure or participation in the study.
  • Patients suffering from asthma, chronic cough, preoperative upper respiratory infection symptoms.
  • Current smoker.
  • Medication involving angiotensin-converting-enzyme inhibitors (ACE-I).
  • Classified as either American Society of Anesthesiologists (ASA) class III or IV.
  • Sinus Bradycardia (<60/min) or history of any type of heart block or Beta-Blockers medication.

研究组 & 干预措施

Group D (Dexmedetomidine)

Experimental

In the Dexmedetomidine group, patients will be given IV bolus infusion of dexmedetomidine

干预措施: Dexmedetomidine (Drug)

Group L (Lidocaine)

Experimental

In the Lidocaine group, the patients will be given an IV bolus infusion of lidocaine

干预措施: Lidocaine IV (Drug)

结局指标

主要结局

compare effectiveness of Dexmedetomidine and intravenous lidocaine in attenuating cough reflex during the tracheal extubation period after thyroid surgery

时间窗: 5 minutes from extubation

the investigators use the following cough score where 0 = no cough, 1 = minimal (single) cough, 2 = moderate (≤5 seconds) cough and 3 = severe (\>5 seconds) cough to reflect the degree of attenuation of air way reflexes for each group

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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