Comparison of Topical and Nebulized Anesthesia in Patients Undergoing Esophago-Gastro-Duodenoscopy
试验速览
- 阶段
- 4 期
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Comparison of Topical and Nebulized Anesthesia
研究概览
简要总结
This study compares the effect of nebulized lidocaine and lidocaine spray in patients undergoing esophago-gastro-duodenoscopy. The investigators evaluate the success rate of the procedure between two methods.
详细描述
This is a randomized-controlled trial in the patients undergoing esophago-gastro-duodenoscopy. The patients are randomized by computer into two arms: nebulized lidocaine and lidocaine spray. Both drugs are applied 15-20 minutes prior the prior the procedure. Only one endoscopist participate in this study. After the procedure finishes, the investigators evaluate the outcome and satisfaction of patients and endoscopist.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective case for esophago-gastro-duodenoscopy with ASA classification 1-2
- •Both genders
- •Age between 18-65 years
排除标准
- •History of smoking
- •Upper respiratory tract infection
- •Heart disease
- •Allergy to local anesthetic drugs
- •Withdrawal or termination criteria
- •Patient refusal
- •Patient develops lidocaine allergy
- •Bronchospasm
- •Sign of Local Anesthetic Toxicity
研究组 & 干预措施
Lidocaine Spray
20 puffs of 10% Lidocaine spray
干预措施: Lidocaine Spray (Drug)
Nebulized Lidocaine
2.5 mL of 10% Lidocaine
干预措施: Nebulized Lidocaine (Drug)
结局指标
主要结局
Comparison of Topical and Nebulized Anesthesia
时间窗: 90 min
Both nurse anesthetist and endoscopist evaluate difficulty during the procedure and demand for additional sedative drugs using numeric scale
次要结局
- Patient Satisfaction(90 min)
- Operator Satisfaction(30 min)