Comparison Between Nebulized Lidocaine, Lidocaine Spray, or Their Combination for Topical Anesthesia During Diagnostic Flexible Bronchoscopy: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- time taken to cross the vocal cords.
研究概览
简要总结
compare the efficacy and safety of nebulized lidocaine, oropharyngeal lidocaine spray, or their combination for better outcome of topical anesthesia in subjects undergoing diagnostic FB; severity of cough , pain during procedure , cumulative dose of anesthesia needed and its adverse reaction , overall satisfaction .
详细描述
Flexible bronchoscopy (FB) is a commonly performed procedure in the diagnosis and treatment of several respiratory disease. Although FB is generally a short procedure, it is uncomfortable for the patient. At least the use of topical anesthesia during FB is essential, especially when performed without sedation. Effective topical anesthesia blunts airway reflexes such as gag, cough, and laryngospasm.
The reduction in cough not only improves patient comfort but also makes the procedure easier for the operator.
Among agents used for topical anesthesia, lidocaine is the most widely used drug because of its safety and favorable pharmacokinetic profile.
Lidocaine is available in various formulations (gel or solution) and can be delivered to the respiratory passages by using different modes (spray, nebulization, transtracheal injection, bronchoscope instillation, and others).
In this study, will compare the efficacy and safety of nebulized lidocaine, oropharyngeal lidocaine spray, or their combination for topical anesthesia in subjects undergoing diagnostic FB, for better outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The study subjects will not be blinded; the bronchoscopist and the assessor of outcomes will be blinded to the group allocation.
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
- •Patients above 18 years old will undergo FB are included in this study.
排除标准
- •known hypersensitivity to lidocaine.
- •Pregnancy.
- •hemodynamic instability.
- •failure to provide informed consent.
结局指标
主要结局
time taken to cross the vocal cords.
时间窗: at the beginning of the procedure(time zero) till seconds after crossing the vocal cords
the median time in seconds will be calculated during the procedure from the introduction the tip of bronchoscope from the nostril to second at which the tip of bronchoscopy cross the the vocal cords.
Changes in oxygen saturation
时间窗: During and within 3 hours after procedure
changes in the oxygen saturation from the baseline before procedure
changes in heart rate
时间窗: During and within 3 hours after procedure
changes in the heart rate from the baseline before procedure
The severity of cough using cough severity index
时间窗: During and within 3 hours after procedure
Assess the severity of cough during and within 4 hours after the procedure as (0 : absent cough is better ) , ( 5 : disturbing cough is the worst )
pain during the procedure rated by the subjects on the Faces Pain Rating Scale.
时间窗: During and within 3 hours after procedure
As (0 : no pain , the best) , ( 10 : worst pain )
次要结局
- cumulative dose of lidocaine administered during the procedure.(During the procedure)
- adverse reactions to lidocaine(During and within 3 hours after procedure)
- overall satisfaction with the procedure using likert scale .(During and within 3 hours after procedure)
研究者
Bassem Gadallah Gad-Elkariem Kalam
Resident doctor at Chest Diseases Department
Assiut University