Randomized controlled trial to study efficacy of 1% vs 2% lignocaine in topical airway anaesthesia in routine bronchoscopy procedures
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- To compare the cough scores during the procedure between two study groups that is 1% lignocaine and 2% lignocaine by using VAS score(0-100mm)
研究概览
简要总结
The aim of this study is to compare the efficacy of two lignocaine strengths that is 1% and 2% in suppressing cough in patients undergoing routine brochoscopy procedures in our hospital setting.Also the study aims at comparing its effect on overall satisfaction of bronchoscopist ,with regards to conduct of the procedure as well as overall satisfaction of patient during the procedure.The optimal concentration of lignocaine to be used in flexible bronchoscopy remains unknown.This randomized controlled trial will try to compare the efficacy of 1% and 2% lignocaine solutions for topical airway anaesthesia during routine bronchoscopy.Patient s will be recruited from outpatient and inpatients under respiratory and pulmonary medicine and the study will be conducted in the bronchoscopy suite of CMC Vellore hospital.It will be conducted as a investigator,patient,outcome asessor,daty entry operator blinded RCT .The main primary outcome is cough score as rated by the operator using VAS scores
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Consecutive patients undergoing flexible bronchoscopy during study period will be considered eligible for inclusion if they are 1.Aged above 18 years 2.Hemodynamically stable(defined systolic B.P>100mmHg,<180mmHg).
排除标准
- •1.Failure to provide informed consent 2.Documented history of lignocaine toxicity 3.Pregnancy 4.Patients undergoing TBNA and other interventions 5.Wherein bronchoscopy was performed through endotracheal or tracheostomy tube.
结局指标
主要结局
To compare the cough scores during the procedure between two study groups that is 1% lignocaine and 2% lignocaine by using VAS score(0-100mm)
时间窗: 1.Immediately after procedure- Cough score as assessed by bronchoscopist,respiratory therapist and staff nurse assisting the procedure | 2.Two hours after procedure-cough score as assessed by patient
次要结局
- To determine overall feel of scopy as assessed by patient based on FACES pain scale score(within 2 hours of procedure)
- To determine total dose of lignocaine (in mg) used while performing procedure for 1% vs 2% concentrations(immediately after the procedure)
- To determine overall feel of scopy for the operator based on VAS score(0-100mm scale)(immediately after the procedure)
- To determine overall complication rate in number while undergoing bronchoscopy procedures in 1% vs 2% lignocaine(immediately after the procedure)