NCT04725695终止4 期
Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy - a Blinded, Randomized, Placebo-controlled Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Ease of intubation
研究概览
简要总结
In this randomized placebo-controlled clinical trial, patients will be randomized to be administered viscous lidocaine or placebo preoperatively to elective upper GI endoscopy
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred to and found fit for upper GI endoscopy in an out patient setting
- •Between 18 and 75 years old
- •Speaks and understands Danish
排除标准
- •Patients admitted for upper GI endoscopy in an in-patient setting
- •Patients with dementia and/or other cognitive dysfunction disorders
- •Patients primarily complaining of dysphagia
- •Patients allergic to lidocaine
- •Patients with suspected retention
- •Patients who will undergo upper GI endoscopy with nurse-assisted propofol sedation
- •Patients who will undergo upper GI endoscopy with assistance of anesthesia-personnel
研究组 & 干预措施
Placebo
Placebo Comparator
Oral viscous solution without active drug, 10 ml
干预措施: Viscous Lidocaine (Drug)
Viscous lidocaine
Experimental
Oral viscous lidocaine 20 mg/ml, 10 ml
干预措施: Viscous Lidocaine (Drug)
结局指标
主要结局
Ease of intubation
时间窗: Immediately after the procedure
The endoscopist will rate the difficulty of intubating the esophagus on a numeric rating scale (NRS) from 0 (worst) to 10 (best)
次要结局
- Patient's perception of discomfort(Immediately after the procedure)
- Ease of examination(Immediately after the procedure)
- Number of intubation attempts(Peroperatively counted by the assisting nurse)
- Number of gag reflexes(Peroperatively counted by the assisting nurse)
- Patient's willingness to be reexamined(Immediately after the procedure)
- Sedation 1(Peroperatively)
- Sedation 2(Peroperatively)
- Perception of gag reflexes(Immediately after the procedure)
研究者
Erling Oma
Principal investigator
Bispebjerg Hospital
研究点 (1)
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