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
- Conditions
- Gastroscopy
- Registration Number
- 2023-509888-24-00
- Lead Sponsor
- Hopital Erasme
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 50
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
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
Epilepsy
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
Porphyria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method estimated EC50 of propofol for gastroscope introduction without movements estimated EC50 of propofol for gastroscope introduction without movements
- Secondary Outcome Measures
Name Time Method throat pain (analog digital scale from 1 to 10) at recovery room discharge, an average of 1 hour after completed procedure throat pain (analog digital scale from 1 to 10) at recovery room discharge, an average of 1 hour after completed procedure
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) 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)
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) ] 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) ]
number of participants with moderate hypoxemia (pulse saturation below 95%) during propofol sedation and gastroscopy 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 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 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 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 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 number of participants presenting side effects of lidocaine administration metallic taste, tinnitus, anaphylaxis
Time to anesthesia recover : Time between stopping Propofol and recovering a MOAA/S score ≥ 4 Time to anesthesia recover : Time between stopping Propofol and recovering a MOAA/S score ≥ 4
Time for post anesthesic care unit discharge Time for post anesthesic care unit discharge
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Trial Locations
- Locations (1)
Hopital Erasme
🇧🇪Anderlecht, Belgium
Hopital Erasme🇧🇪Anderlecht, BelgiumBOUDART CélineSite contact+32484941133celine.boudart@hubruxelles.be