The Optimal Timing of the Initiation of Esophagogastroduodenoscopy After Oral Lidocaine Spray
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Blood pressure change
研究概览
简要总结
Esophagogastroduodenoscopy (EGD) is the main examination in the upper gastrointestinal field. Aspiration pneumonia may happen if choking occurs during the EGD insertion, and the exam quality and efficacy may be affected if gag reflex occurs. The endoscopist may terminate the exam to avoid complications if the patient could not obey the orders. To reach the high quality of EGD examination and to avoid possible complications, the patient's comfort and compliance during the EGD examination are important. Sedation using propofol can improve the patient's comfort and compliance. However, in patients unsuitable for systemic anesthesia, local lidocaine spray at pharynx is performed instead. Until now, there is no standardization of the waiting time between lidocaine spray and the initiation of EGD. This study aimed to investigate the optimal timing of the initiation of esophagogastroduodenoscopy after lidocaine spray.
详细描述
This study compares the 1-minute waiting time and 3-minute waiting time between the lidocaine spray and the EGD initiation. During the topical anesthesia stage, investigators give local spray with 6 puff on pharynx at the 0 minute in both groups. After the waiting time, EGD is inserted.
The baseline heart rate and blood pressure were recorded before EGD and during the EGD passing through pharynx respectively. After the whole procedure, enrolled patients will fill in the EGD quality questionnaire.
Through this study, investigators can figure out whether 1 minute or 3 minutes may be the optimal waiting time after lidocaine spray.
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, Investigator)
盲法说明
Sealed and ordered envelope will be opened by assistant and the allocation was written on it. After then, lidocaine spray will be administered. The operator will be informed to prepare 30 seconds before the EGD initiation.
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants included patients aged ≥ 20 years who scheduled EGD from OPD for dyspepsia, peptic ulcer disease, GERD, subepithelial lesion evaluation, and diarrhea
排除标准
- •GI bleeding
- •endoscopic submucosal dissection due to prolonged scheduled procedure time
- •patients from emergency department or ward
研究组 & 干预措施
1-minute group
6 puff of lidocaine was delivered 1 minute before the initiation of EGD insertion
干预措施: Lidocaine (Drug)
3-minute group
6 puff of lidocaine was delivered 3 minutes before the initiation of EGD insertion
干预措施: Lidocaine (Drug)
结局指标
主要结局
Blood pressure change
时间窗: 1 day
The increase level of systolic blood pressure between baseline and during the pharynx insertion of EGD
Heart rate change
时间窗: 1 day
The increase level of heart rate between baseline and during the pharynx insertion of EGD
次要结局
- EGD comfort quality questionnaire score(1 day)
研究者
Hsueh-Chien Chiang
Principal Investigator
National Cheng-Kung University Hospital