Nebulized Lignocaine for Topical Airway Anesthesia During Flexible Bronchoscopy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Operator rated overall procedure satisfaction VAS
研究概览
简要总结
Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be significantly improved with control of cough. Use of sedation during bronchoscopy has been reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is routinely performed at many centres including ours.
Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is limited literature on the efficacy of lignocaine delivered with the nebulized route during awake flexible bronchoscopy. This study would help to determine the utility of nebulized lignocaine in airway anaesthesia during flexible bronchoscopy.
详细描述
For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo flexible bronchoscopy would be randomised in a one is to one ratio either to nebulized lignocaine (4%) or saline (placebo) nebulization group. Prior to the bronchoscopy blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded at the baseline Patients in both the groups shall be prepared in a similar fashion except for the nebulized lignocaine. Patient, Operator, outcome assessor will be blinded to the allocation.
During the procedure, 1.5ml aliquots of 1% lignocaine will be delivered through the bronchoscope using spray-as-you go technique. The patients would be monitored for any adverse effects throughout the procedure. The bronchoscopist doing the procedure will be provided 2 VAS charts to mark the severity of cough and overall procedure satisfaction.
Post procedure, patients will record the pain experienced while undergoing the procedure on the faces pain rating scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (Age > 18 years) patients undergoing diagnostic or therapeutic flexible bronchoscopy
排除标准
- •Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3
- •Bronchoscopy done through endotracheal or tracheostomy tube
- •Not willing to provide informed consent.
- •Patient requiring sedation for flexible bronchoscopy
- •Patients with known allergy to lignocaine -
研究组 & 干预措施
Nebulized Lignocaine
4% Lignocaine administered as nebulization for topical anaesthesia during bronchoscopy procedure
干预措施: Lignocaine Nebulization (Drug)
Nebulized Saline
Normal Saline administered as nebulization for topical anaesthesia during bronchoscopy procedure
干预措施: Saline Nebulization (Drug)
结局指标
主要结局
Operator rated overall procedure satisfaction VAS
时间窗: At study completion approx. 12 months
Operator rated cough VAS
时间窗: At study completion approx. 12 months
次要结局
- Total dose of Lignocaine administered (mg)(At study completion approx. 12 months)
- Number of patients receiving dose >8.2mg/Kg(At study completion approx. 12 months)
研究者
Karan Madan
Dr Karan Madan MD, DM Assistant Professor
All India Institute of Medical Sciences, New Delhi