Does Intravenous Lidocaine Reduce Propofol Consumption and the Side Effects of Sedation During Gastroscopy in ASA 1 and 2 Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- total propofol dose in milligramme
研究概览
简要总结
The goal of this clinical trial is to assess if intravenous administration of linisol reduce the propofol consumption and the sides effects of sedation during gastroscopy in healthy patients (ASA 1 and 2 patients).
Prior to propofol sedation, participants will receive either an intravenous bolus of linisol (1.5 mg/kg) = treated group or placebo = control group.
After the gastroscopy, patients will be asked to complete a satisfaction questionnaire
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)
盲法说明
computered randomisation, sealed enveloppes linisol versus placebo prepared by anesthesist not involved in the study or in patient care
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
- •Patients scheduled for gastroscopy under narcosis and who have signed the consent.
- •ASA score: 1 and 2
- •BMI between 18 and 30 kg/m2
排除标准
- •Lidocaine allergy
- •Anesthesia within the last 7 days
- •Use of local anesthesia in the last 24 hours
- •Rhythm disorder or HR <50
- •Pregnant women and breastfeeding
- •Participation in another clinical study in the last months
- •Cannot understand VAS score or French
- •Severe central nervous disease and mental illness.
- •obstructive sleep apnea (known or STOP BANG score >5)
- •Upper lung infection.
- •Liver or kidney function disorder
研究组 & 干预措施
Linisol
Patients will receive 1.5 mg/kg of intravenous linisol before propofol sedatation and gastroscope introduction
干预措施: Lidocaine 2% Injectable Solution (Drug)
Linisol
Patients will receive 1.5 mg/kg of intravenous linisol before propofol sedatation and gastroscope introduction
干预措施: Propofol injection (Drug)
Linisol
Patients will receive 1.5 mg/kg of intravenous linisol before propofol sedatation and gastroscope introduction
干预措施: gastroscopy (Procedure)
Sham
Patients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction
干预措施: Saline administration as placebo (Drug)
Sham
Patients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction
干预措施: Propofol injection (Drug)
Sham
Patients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction
干预措施: gastroscopy (Procedure)
结局指标
主要结局
total propofol dose in milligramme
时间窗: Procedure (from the beginning of propofol infusion until endoscope removal)
total propofol dose consumed
propofol in site effet concentration in microgram per milliliter
时间窗: Procedure (from the beginning of propofol infusion until endoscope removal)
AIVOC : Effect concentration of propofol
次要结局
- number of participants presenting cough(Procedure (during propofol sedation and gastroscopy))
- number of participants with hypotension(Procedure (during propofol sedation and gastroscopy))
- number of participants with severe hypoxemia(Procedure (during propofol sedation and gastroscopy))
- number of participants with moderate hypoxemia(Procedure (during propofol sedation and gastroscopy))
- number of participants presenting side effects of lidocaine administration(during gastroscopy procedure)
- score of Endoscopist satisfaction (1-5)(completed procedure (before transfer to recovery room))
- number of participants presenting laryngospasm(Procedure (during propofol sedation and gastroscopy))
- number of participants presenting involuntary movements(Procedure (during propofol sedation and gastroscopy))
- score of Patient satisfaction (1-5)(at recovery room discharge, an average of 1 hour after completed procedure)
- throat pain(at recovery room discharge, an average of 1 hour after completed procedure)
研究者
Omar Assam
principal investigator
Erasme University Hospital