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

Does Intravenous Lidocaine Reduce ED 50 for Propofol Administered Using Target Controlled Infusion (TCI) During Gastroscopy in ASA 1 and 2 Patients.

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 Overview

• Status: Recruiting
• Conditions: Diagnostic Gastroscopy
• Intervention / Treatment: Drug: Lidocaine 2% Injectable Solution; Procedure: gastroscopy; Drug: Saline administration as placebo; Drug: Propofol injection

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Céline Boudart, PhD; Phone Number: +322555391+9; Email: celine.boudart@hubruxelles.be

Study Locations

• Belgium
  • Bruxelles, Belgium, 1070
    • Recruiting
    • Boudart Céline
    • Contact: boudart céline, MD; PhD; Phone Number: +32484941133; Email: celine.boudart@hubruxelles.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Linisol; Patients will receive 1.5 mg/kg of intravenous linisol before propofol sedatation and gastroscope introduction	Drug: Lidocaine 2% Injectable Solution; administration of a bolus of lidocaine 1.5 mg/kg; Procedure: gastroscopy; esogastroduodenoscopy; Drug: Propofol injection; Sedation by total intravenous administration (TIVA) of propofol using target controlled infusion (TCI)
Placebo Comparator: Control; Patients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction	Procedure: gastroscopy; esogastroduodenoscopy; Drug: Saline administration as placebo; administration of a bolus of saline solution as a placebo; Other Names: administration of a bolus of saline solution as a placebo; Drug: Propofol injection; Sedation by total intravenous administration (TIVA) of propofol using target controlled infusion (TCI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ED50 of propofol	ED50 of propofol for gastroscope introduction without movements	gastroscope introduction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participants with moderate hypoxemia	pulse saturation below 95%	Procedure (during propofol sedation and gastroscopy)
number of participants presenting cough	cough suggesting to light sedation	Procedure (during propofol sedation and gastroscopy)
number of participants presenting laryngospasm	laryngospasm suggesting to light sedation	Procedure (during propofol sedation and gastroscopy)
number of participants presenting involuntary movements	involuntary movements suggesting to light sedation	Procedure (during propofol sedation and gastroscopy)
score of Endoscopist satisfaction (1-5)	Endoscopist satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent	completed procedure (before transfer to recovery room)
score of Patient satisfaction (1-5)	Patient satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent	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
number of participants with hypotension	mean arterial pressure below 65 mmHg	Procedure (during propofol sedation and gastroscopy
number of participants presenting side effects of lidocaine administration	metallic taste, tinnitus, anaphylaxis	Time Frame: during gastroscopy procedure
Time to anesthesia recover	Time between stopping Propofol and recovering a MOAA/S score ≥ 4	completed procedure (before transfer to recovery room)
Time for post anesthesic care unit discharge	Time between arrival and discharge of the post anesthesic care unit (Aldrette score >9)	at recovery room discharge, an average of 1 hour after completed procedure

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Principal Investigator: Céline Boudart, PhD, Erasme Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Propofol; Lidocaine; Pharmaceutical Solutions
• Other Study ID Numbers: SRB2023309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after publication
• IPD Sharing Access Criteria: data will be provided anonymously upon request by email from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No