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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

Phase 4
Not yet recruiting
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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
estimated EC50 of propofol for gastroscope introduction without movements

estimated EC50 of propofol for gastroscope introduction without movements

Secondary Outcome Measures
NameTimeMethod
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

Trial Locations

Locations (1)

Hopital Erasme

🇧🇪

Anderlecht, Belgium

Hopital Erasme
🇧🇪Anderlecht, Belgium
BOUDART Céline
Site contact
+32484941133
celine.boudart@hubruxelles.be

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