Evaluation of the Efficacy and Safety of Administering Lidocaine Spray in Oesophago-gastro-duodenoscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 586
- 试验地点
- 1
- 主要终点
- Degree of tolerance referred by the endoscopist in each group.
研究概览
简要总结
This study evaluates the efficacy and safety of the administration of lidocaine spray in oesophago-gastro-duodenoscopies. Half of the patients will receive lidocaine spray, while the other half will receive a placebo.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Stomach or esophagus diagnosed cancer
- •Giant hiatal hernia diagnosed
- •Zenker's diverticulum diagnosed
- •Achalasia diagnosed
- •Patients aged over 70
- •Medical history of moderate to severe liver disease
- •Medical history of moderate to severe renal insufficiency
- •Medical history of moderate to severe Obstructive Sleep Apnea Syndrome (OSA) (AHI≥15).
- •Severe respiratory insufficiency(asmtha or COPD) diagnosed
- •Patients with encephalopaty active
- •Patients with medical history of methemoglobinemia
- •Patients with history of drug abuse
- •Patients with mental impairment
- •Patients with BMI≥ 35
- •Use of pediatric tube
研究组 & 干预措施
Lidocaine
Five lidocaine solution puffs (10mg lidocaine/puff) on the four posterior quadrants of the pharynx and on the base of the tongue, 3 minutes before the oesophago-gastro-duodenoscopy.
干预措施: Lidocaine (Drug)
Control
Five placebo solution puffs on the four posterior quadrants of the pharynx and on the base of the tongue, 3 minutes before the oesophago-gastro-duodenoscopy
干预措施: Placebo (Drug)
结局指标
主要结局
Degree of tolerance referred by the endoscopist in each group.
时间窗: Up to 15 minutes after endoscopy
Establish degree of tolerance referred by the endoscopist in each group according to the scale defined by Leich et al ( Gastrointestinal Endosc 1993;39:384-7)
次要结局
- Estimate the total dose of propofol used in each group(15 minutes before endoscopy)
- Endoscopist's level of satisfaction with the procedure in each group(Up to 15 minutes after endoscopy)
- Patient's level of satisfaction with the procedure in each group.(Up to 15 minutes after endoscopy)
- Degree of tolerance referred by the patient in each group(Up to 15 minutes after endoscopy)
- Establish and compare the number of adverse events detected in control and lidocaine group(Up to 15 minutes after endoscopy)
- Number of completed procedures in control and lidocaine group(Up to 15 minutes after endoscopy)
- Estimate the number of patients with retrograde amnesia in each group(Up to 15 minutes after endoscopy)
- Estimate the number of patients with cough in each group(Up to 15 minutes after endoscopy)
- Estimate the number of patients with oropharyngeal discomfort in each group.(Up to 15 minutes after endoscopy)
研究者
Irene Martin Marcos
Registered Nurse
Basque Health Service