Comparative Study Between Transcutaneous Ultrasonography and Direct Laryngoscopy for Assessment of Vocal Cord Mobility at the End of Thyroidectomy Operation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Early assessment of vocal cord injury
研究概览
简要总结
The aim of work of this study is to evaluate Transcutanous Ultrasonogrphy for assessment of vocal cord mobility in comparison to Direct laryngoscopy during extubation after thyroidectomy
详细描述
The aim of work of this study is to evaluate Transcutanous Ultrasonogrphy for assessment of vocal cord mobility in comparison to Direct laryngoscopy during extubation after thyroidectomyA. Preoperative settings: All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation and vocal cord mobility and voice quality be assessed by ENT and anesthesiologist by ultrasound.
B. Intraoperative settings:
On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure, and pulse oximetry will be applied. Baseline parameters such as heart rate (HR) , blood pressure (BP), and oxygen saturation (SpO2) will be also recorded.
Intravenous (IV) line will be inserted and IV lactated Ringer 500ml bolus then started as calculated by fluid chart. For both groups, General anesthesia will be performed After 3 minutes of pre- oxygenation, anaesthesia will be induced with IV 1 mcg/kg of fentanyl, 2 mg/kg of propofol and 0.5 mg/kg of atracurium to facilitate endotracheal intubation.
- Anesthesia will be maintained with 50% of oxygen in air, 1-2 % isoflurane and 0.1mg/kg atracurium every 20 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Investigator)
盲法说明
Investigator and anesthesiologist were blinded to results in the end of surgery
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes patients aged above 21 years
- •BMI<40kg/m2
- •American Society of Anesthesiologists(ASA) Physical Status Class- II and class- III
- •Scheduled for elective thyroid surgery with intact vocal cords
- •Approved to give informed consent and preoperative assessment by ENT specialist using Indirect laryngoscopy.
排除标准
- •Patient refused to participate.
- •Morbid obesity (BMI: >40kg/m^2)
- •Age below 21 years.
- •American Society of Anesthesiologists(ASA) Physical Status Class IV.
- •Previous operation in thyroid gland.
- •Any previous vocal cords paralysis.
研究组 & 干预措施
Direct laryngoscopy
Direct laryngoscopy is a gold standard device to visualise the larynx and vocal cord mobility after thyroidectomy operation , that allows assessment of vocal cords mobility before extubation after thyroidectomy operation,we assess mobility with endotracheal tube and without endotracheal tube
干预措施: Thyroidectomy operation is a surgical removal of thyroid, injury of recurrent laryngeal nerve one of common complications of thyroidectomy Which can affect Vocal cords mobility (Procedure)
Transcutanous ultrasonography
Transcutanous ultrasonography is a tool non invasive reliable diagnostic method to assess vocal cords mobility , which can assess vocal cords mobility before extubation , that may be helpful to exclude recurrent laryngeal nerve injury as early as possible ,that may protect the patient from any possible complications
干预措施: Thyroidectomy operation is a surgical removal of thyroid, injury of recurrent laryngeal nerve one of common complications of thyroidectomy Which can affect Vocal cords mobility (Procedure)
结局指标
主要结局
Early assessment of vocal cord injury
时间窗: Immediately after the surgery
Early detection of any recurrant laryngeal nerve injury or paralysis at the end of surgery by vocal cords mobility examined by investigator by TLUS and by direct laryngeoscopy by anesthesiologist.
次要结局
- Transcutanous laryngeal ultrasonography(Perioperatively)
- Direct laryngoscopy adverse effects(Perioperatively)