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 1

• Conditions: Gastroscopy; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: CTIS2023-509888-24-00
• Lead Sponsor: Hopital Erasme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-14
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary = to evaluate the impact of an intravenous Lidocaine bolus (1.5 mg/kg ideal body weight) on the estimated<br>median effective concentration (EC50) of Propofol used during intravenous target concentration anesthesia<br>(AIVOC.: Schnider model) for gastroscopy.;Secondary Objective: Secondary = potential reduction in Propofol side effects (arterial hypotension / desaturation / apnea / bradycardia), lower incidence of pain on Propofol injection, lower incidence of coughing on gastroscope insertion, faster post-procedure recovery, lower incidence of throat pain, shorter time in post-anesthesia care unit, and at least equivalent patient satisfaction and gastroenterologist satisfaction with the endoscopic procedure.;Primary end point(s): estimated EC50 of propofol for gastroscope introduction without movements