2023-509888-24-00招募中4 期
Effect of intravenous Lidocaine bolus on the median effective concentration (EC50) of Propofol during target controlled infusion (TCI : Schnider model) for gastroscopy in adult patients : a prospective, randomized, double-blinded study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- estimated EC50 of propofol for gastroscope introduction without movements
研究概览
简要总结
Primary = to evaluate the impact of an intravenous Lidocaine bolus (1.5 mg/kg ideal body weight) on the estimated median effective concentration (EC50) of Propofol used during intravenous target concentration anesthesia (AIVOC.: Schnider model) for gastroscopy.
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 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •All patients having to benefit from gastroscopy under narcosis at the ERASME hospital
- •Age between 18-65 years
- •ASA score I or II (American Society of Anesthesiologists)
- •Body mass index (BMI) between 18 and 30 kg/m2
- •Knowledge of French / French speakers
- •Signed written informed consent
排除标准
- •Any allergy or contraindication to one or more of the substances used
- •Pregnant or breast-feeding at the time of the study
- •History of intoxication by local anesthetics
- •Indication for oro-tracheal intubation
- •Emergency gastroscopy
- •Pre-gastroscopy premedication
- •Chronic consumption of powerful analgesics / drug addiction
- •Psychiatric disorder
- •Severe renal failure (GFR < 30 ml/min/1.73m2)
- •History of malignant hyperthermia
- •Severe liver failure
- •Blood coagulation disorders
- •Anticoagulant medication
- •Upper lung infection
- •Mitochondrial disease
- •Drug interaction with Propofol and/or Lidocaine: concomitant use of Rifampicine, Valproate, Phenytoin, Cardiac glycosides (Digoxin), Class III antiarrhythmics (Amiodarone), Cimetidine, Barbiturates, Isoprenaline, Glucagon
- •Cardiac arrhythmia (bradycardia < 50/min, atrioventricular block II-III, severe sino-atrial block)
- •Severe heart failure (LVEF < 30%)
- •Obesity (BMI > 30 kg/m2)
- •Proven sleep apnea syndrome or suspected sleep apnea syndrome with STOP-BANG score > 5
- •Have undergone local anesthesia within the previous 24 hours or general anesthesia within the previous 7 days
- •Methemoglobinemia
结局指标
主要结局
estimated EC50 of propofol for gastroscope introduction without movements
estimated EC50 of propofol for gastroscope introduction without movements
次要结局
- score of Endoscopist satisfaction (1-5) after completion of the procedure (Endoscopist satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent)
- number of participants with moderate hypoxemia (pulse saturation below 95%) during propofol sedation and gastroscopy
- number of participants with hypotension (mean arterial pressure below 65 mmHg) during propofol sedation and gastroscopy
- number of participants presenting cough cough suggesting to light sedation during propofol sedation and gastroscopy
- number of participants presenting laryngospasm laryngospasm suggesting to light sedation during propofol sedation and gastroscopy
- number of participants presenting involuntary movements involuntary movements suggesting to light sedation during propofol sedation and gastroscopy
- number of participants presenting side effects of lidocaine administration metallic taste, tinnitus, anaphylaxis
- score of Patient satisfaction (1-5) at recovery room discharge, an average of 1 hour after completed procedure (Patient satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent) ]
- throat pain (analog digital scale from 1 to 10) at recovery room discharge, an average of 1 hour after completed procedure
- Time to anesthesia recover : Time between stopping Propofol and recovering a MOAA/S score ≥ 4
- Time for post anesthesic care unit discharge
研究者
Pr Boudart Céline
Scientific
Hopital Erasme
研究点 (1)
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