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

Erasme University Hospital50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Diagnostic Gastroscopy

Interventions

Lidocaine 2% Injectable SolutionDRUG

administration of a bolus of lidocaine 1.5 mg/kg

Saline administration as placeboDRUG

administration of a bolus of saline solution as a placebo

Propofol injectionDRUG

Sedation by total intravenous administration (TIVA) of propofol using target controlled infusion (TCI)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Boudart Céline

Brussels, Belgium

RECRUITING

Outcomes

Primary Outcomes

ED50 of propofol

ED50 of propofol for gastroscope introduction without movements

Time frame: gastroscope introduction

Secondary Outcomes

number of participants with moderate hypoxemia

pulse saturation below 95%

Time frame: Procedure (during propofol sedation and gastroscopy)

number of participants with hypotension

mean arterial pressure below 65 mmHg

Time frame: Procedure (during propofol sedation and gastroscopy

number of participants presenting cough

cough suggesting to light sedation

Time frame: Procedure (during propofol sedation and gastroscopy)

number of participants presenting laryngospasm

laryngospasm suggesting to light sedation

Time frame: Procedure (during propofol sedation and gastroscopy)

number of participants presenting involuntary movements

involuntary movements suggesting to light sedation

Time frame: Procedure (during propofol sedation and gastroscopy)

number of participants presenting side effects of lidocaine administration

metallic taste, tinnitus, anaphylaxis

Time frame: Time Frame: during gastroscopy procedure

score of Endoscopist satisfaction (1-5)

Endoscopist satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent

Central Contacts

Céline Boudart, PhD

CONTACT

+322555391+9 celine.boudart@hubruxelles.be

Data from ClinicalTrials.gov

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