Ended Therapeutic use (Phase IV) Gastroscopy

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

EU CTIS ID: 2023-509888-24-00

What this study is testing

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.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.