A Randomized Controlled Trial to Evaluate the Efficacy of Topical Pharyngeal Anaesthesia Using 5 vs 10 Sprays of 10% Lignocaine During Flexible Bronchoscopy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Operator rated overall procedure satisfaction
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.
Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is uncertainty regarding the adequate dose of lignocaine sprays for pharyngeal anaesthesia during flexible bronchoscopy. This study would help to determine the optimal dose of lignocaine sprays for pharyngeal anaesthesia during flexible bronchoscopy.
详细描述
For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. Enrolled patients will be randomized to receive either 5 or 10 sprays of 10% lignocaine to the pharynx. This will be followed by the standard topical anesthesia procedure followed in our institution involving 5ml of 2% lignocaine gel into the nostril. Transnasal flexible bronchoscopy will be performed with additional 1% lignocaine administered as "spray as you go" method. This will be given as 2 ml aliquots- with similar volume in both groups as baseline. Procedure shall be performed with administration of sedation using Midazolam and Fentanyl if required. Primary outcome will be assessed by noting the operator rated overall procedure satisfaction as a VAS scale score.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Group allocation by opaque sealed envelopes. Participant and bronchoscopist shall be unaware of the number of sprays administered.
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
- •All adults ≥ 18 yrs of age undergoing flexible bronchoscopy
排除标准
- •Uncontrolled hypertension Systolic Blood Pressure >180 mm Hg
- •Symptomatic coronary artery disease
- •Pregnancy
- •Not giving informed consent for the procedure
- •Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3
- •Bronchoscopy performed through an artificial airway
研究组 & 干预措施
5 sprays
5 sprays of 10% lignocaine administered for topical anaesthesia during flexible bronchoscopy
干预措施: 5 sprays of 10% lignocaine (Drug)
10 sprays
10 sprays of 10% lignocaine administered for topical anaesthesia during flexible bronchoscopy
干预措施: 10 sprays of 10% lignocaine (Drug)
结局指标
主要结局
Operator rated overall procedure satisfaction
时间窗: At study completion at approximately 4 months
Visual Analogue Scale score (VAS) between 0 to 100
次要结局
- Operator rated cough(At study completion at approximately 4 months)
- Time from bronchoscope introduction to reaching the vocal cords(At study completion at approximately 4 months)
- Patient willingness to return for repeat bronchoscopy(At study completion at approximately 4 months)
- Cumulative lignocaine dose(At study completion at approximately 4 months)
- Complications(At study completion at approximately 4 months)
研究者
Karan Madan
Dr Karan Madan, Assistant Professor, Department of Pulmonary Medicine and Sleep Disorders
All India Institute of Medical Sciences, New Delhi