Airway Nerve Block Versus Nebulization by Lignocaine During Diagnostic Flexible Bronchoscopy Under Moderate Sedation. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- Global Tolerance Score
研究概览
简要总结
To compare the effectiveness of nebulization versus airway nerve block technique to achieve upper airway anesthesia for diagnostic fiberoptic bronchoscopy under moderate sedation.
详细描述
Randomization was done using computer generated tables of random numbers:
Group A (nebulized lignocaine group) as a control group (n = 60) received 5 ml of 10% lignocaine by air driven jet nebulizer for 20 min .
Group B (nerve block group) (n = 60) received bilateral superior laryngeal nerve block and trans-tracheal instillation of 4 ml of 2% lignocaine, along with viscous xylocaine gargles twice.
Patient tolerance was assessed using the Global Tolerance Score, based on a visual analogue scale ( VAS).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients planned for diagnostic fiberoptic procedures such as broncho-alveolar lavage, endobronchial or transbronchial biopsies, or brush cytology.
排除标准
- •Patients less than 21yrs old and patients more than 70 yrs old.
- •Severe respiratory failure (pH < 7.35, partial arterial oxygen pressure <55 mmHg despite supplemental oxygen).
- •Upper airway surgery or radiation, allergy to lidocaine, Propofol or midazolam, or bleeding disorder.
- •Hemodynamic instable patient or patient decompensated heart failure.
- •Epileptic patients, severe neurological or psychiatric disorder.
- •Patients requiring cryo-biopsy or endobronchial ultrasound because these procedures are performed under deep sedation including fiberoptic intubation.
结局指标
主要结局
Global Tolerance Score
时间窗: First two hours in the postoperative period
The Tolerance Score, defined as the arithmetic mean of global tolerance visual analogue score (VAS)and the mean of scores for the 4 specific sensations, was calculated.
次要结局
未报告次要终点