Intravenous Lidocaine to Reduce ED50 for Propofol Administered Using Target Controlled Infusion (TCI) During Gastroscopy

Free University of Brussels (ULB)

Status: Enrolling

Conditions: Diagnostic Gastroscopy

Treatments: Procedure: gastroscopy; Drug: Propofol injection; Drug: Saline administration as placebo; Drug: Lidocaine 2% Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06143410

SRB2023309

Details and patient eligibility

About

The goal of this prospective, interventionnal clinical trial is to assess if intravenous administration of linisol reduce the ED50 of propofol when administered using Target Controlled Infusion (TCI) during gastroscopy in healthy patients (ASA 1 and 2 patients).

Prior to propofol sedation, participants will receive either an intravenous bolus of linisol (1.5 mg/kg) = treated group or placebo = control group.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for gastroscopy under narcosis and who have signed the consent.
• ASA score: 1 and 2
• BMI between 18 and 30 kg/m2

Exclusion criteria

• Lidocaine allergy
• Anesthesia within the last 7 days
• Use of local anesthesia in the last 24 hours
• Rhythm disorder or HR <50
• Pregnant women and breastfeeding
• Participation in another clinical study in the last months
• Cannot understand VAS score or French
• Severe central nervous disease and mental illness.
• Obstructive sleep apnea (known or STOP BANG score >5)
• Upper lung infection.
• Liver or kidney function disorder

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Linisol

Active Comparator group

Description:

Patients will receive 1.5 mg/kg of intravenous linisol before propofol sedatation and gastroscope introduction

Treatment:

Drug: Lidocaine 2% Injectable Solution

Procedure: gastroscopy

Drug: Propofol injection

Control

Placebo Comparator group

Description:

Patients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction

Treatment:

Procedure: gastroscopy

Drug: Propofol injection

Drug: Saline administration as placebo