A comparative evaluation between ultrasound guided airway nerve block and ultrasonic nebulisation with lignocaine for awake fiberoptic intubation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Cough reflex
研究概览
简要总结
To compareefficacy between nebulized lignocaine and ultrasoundguided airway nerve blocks for awake fiberoptic intubation.
To assess cough reflex and gag reflexduring awake fiberopticintubation
A prospective, randomized, observerblinded study. Sample size - with confidence interval 95%, α is0.05 , powerof 80%, β is 0.2,60 patients are needed.
A written informed consent.
Randomly assigned into 2 groups by usingsealed envelope technique.
Standard fastingprotocol and anti-aspiration prophylaxis.
GROUP 1 (LA) – NEBULISATION WITH 4ML OFLIGNOCAINE 4%
GROUP 2 (UAB) – USG GUIDED AIRWAY NERVE BLOCK– 2mlof 2% lignocaine - B/L superior laryngeal nerve andrecurrent laryngeal nerve.
Confirmation ofthe tube in the trachea by end-tidal capnography.
•Hemodynamic parameters,such as systolic blood pressure (SBP), diastolic blood pressure (DBP), HR, SpO2 , ECG will be recorded as base linein preoperative room. Then vitals will be recorded during FOB intubation, immediately afterintubation, 5 min, 15 min of intubation inside OT.
•Gag reflex, cough reflex, vocal cordposition will be noted during intubation
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Mallampati grade 3 & 4 or inter-incisor distance <2.5 cm ASA grade 1,2,3 Patients having mouth opening < 3 fingers, patients with a short neck and long teeth, micrognathia, obesity and cellulitis of the tongue.
- •Large oropharyngeal tumors, obstructing laryngeal tumors, congenital and acquired maxillofacial deformities, ankylosis of the temporomandibular joints, fractures or ankylosing spondylitis of the cervical spine, and all patients with a history of previous intubation problems.
- •Trauma – facial lacerations/ fractures, cervical spine instability, upper airway lacerations etc.
排除标准
- •Significant glottis and subglottic obstructions Blood and secretions in oral cavity Allergy to local anesthetics / ultrasound gel Hemodynamic instability Infection at local site Previous neck surgery Epileptics.
结局指标
主要结局
1. Cough reflex
时间窗: 1. Cough reflex at a time point when fibreoptic bronchoscope is passing through pharynx, during awake intubation | 2. Gag reflex at a time point when fibreoptic bronchoscope is passing through larynx, during awake intubation
2. Gag reflex
时间窗: 1. Cough reflex at a time point when fibreoptic bronchoscope is passing through pharynx, during awake intubation | 2. Gag reflex at a time point when fibreoptic bronchoscope is passing through larynx, during awake intubation
次要结局
- Heart rate, blood pressure, partial pressure of oxygen saturation(1. Pre-operatively at a time point 10 minutes before shifting to operation theatre)
- Duration of intubation(Time point from entry of fibreoptic bronchoscope through nose to the endotracheal tube placement, during awake intubation)
- Facial grimace
- Vocal cord visibility(At a time point when fiberoptic bronchoscope is passing through vocal cord)