Usefulness of Applying Lidocaine as Topical Pharyngeal Anaesthesia in Esophagogastroduodenoscopies Performed Under Sedation With Propofol- a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy
研究概览
简要总结
The purpose of this study is to determine the efficacy of application of the anaesthesia topical pharyngeal with lidocaine in esophagogastroduodenoscopy under propofol´s sedation, in therms of dosage and side effect´s reduction overall.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient´s over 18 years old that received standard indication for sedated esophagogastroduodenoscopy (American Society of Gastrointestinal Endoscopy Guidelines) in our centre between the period of study.
排除标准
- •Patients under 18 years old
- •Unable to obtain inform´s consent
- •Emergency endoscopy
- •Pregnant women
- •Encephalopathy
- •Well known allergic reaction to propofol, amide-anaesthesics, soy or eggs
- •Methaemoglobinemia induced factor risks
- •No previous or unknown fasting
研究组 & 干预措施
Lidocaine group
Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD)
干预措施: Lidocaine (Drug)
Placebo
Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy
时间窗: 8 months
The propofol will be administered by an expert anaesthetist in repeated bolus (10-20 mg each 30-60 seconds) after an initial induction dosage (0.5-0.6 mg/kg ASA (American Society of Anaesthesiologists) I-II or 0.25-0.35 mg/kg ASA III-IV) to obtain an uniform level of sedation (OAAS 3 and bispectral index (BIS) 70-80) and adequate perceived patient tolerance (no gag-reflex, cough, sudden movements).
次要结局
- Percentage of Participants With Adverse Events in Both Groups(Participants will be followed for the duration of hospital stay, an expected average of 2 hours postprocedure)
- Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist(8 months)
- Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist(8 months)
研究者
Felipe de la Morena Lopez MD
Gastroenterologist. Head of endoscopy
Hospital Universitario Infanta Cristina