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

Sponsor
Erasme University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06143410
Collaborator
(none)
50
Enrollment
2
Arms
7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lidocaine 2% Injectable Solution
  • Drug: Saline administration as placebo
  • Drug: Propofol injection
  • Procedure: gastroscopy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
computered randomisation, sealed enveloppes linisol versus placebo prepared by anesthesist not involved in the study or in patient care
Primary Purpose:
Supportive Care
Official Title:
Does Intravenous Lidocaine Reduce ED 50 for Propofol Administered Using Target Controlled Infusion (TCI) During Gastroscopy in ASA 1 and 2 Patients.
Anticipated Study Start Date :
Feb 1, 2024
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

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

Drug: Propofol injection
Sedation by total intravenous administration (TIVA) of propofol using target controlled infusion (TCI)

Procedure: gastroscopy
esogastroduodenoscopy
Placebo Comparator: Control

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

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)

    Procedure: gastroscopy
    esogastroduodenoscopy

    Outcome Measures

    Primary Outcome Measures

    1. ED50 of propofol [gastroscope introduction]

      ED50 of propofol for gastroscope introduction without movements

    Secondary Outcome Measures

    1. number of participants with moderate hypoxemia [Procedure (during propofol sedation and gastroscopy)]

      pulse saturation below 95%

    2. number of participants with hypotension [Procedure (during propofol sedation and gastroscopy]

      mean arterial pressure below 65 mmHg

    3. number of participants presenting cough [Procedure (during propofol sedation and gastroscopy)]

      cough suggesting to light sedation

    4. number of participants presenting laryngospasm [Procedure (during propofol sedation and gastroscopy)]

      laryngospasm suggesting to light sedation

    5. number of participants presenting involuntary movements [Procedure (during propofol sedation and gastroscopy)]

      involuntary movements suggesting to light sedation

    6. number of participants presenting side effects of lidocaine administration [Time Frame: during gastroscopy procedure]

      metallic taste, tinnitus, anaphylaxis

    7. score of Endoscopist satisfaction (1-5) [completed procedure (before transfer to recovery room)]

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

    8. score of Patient satisfaction (1-5) [at recovery room discharge, an average of 1 hour after completed procedure]

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

    9. throat pain [at recovery room discharge, an average of 1 hour after completed procedure]

      analog digital scale from 1 to 10

    10. Time to anesthesia recover [completed procedure (before transfer to recovery room)]

      Time between stopping Propofol and recovering a MOAA/S score ≥ 4

    11. Time for post anesthesic care unit discharge [at recovery room discharge, an average of 1 hour after completed procedure]

      Time between arrival and discharge of the post anesthesic care unit (Aldrette score >9)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Erasme University Hospital

    Investigators

    • Principal Investigator: Céline Boudart, PhD, Erasme hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Erasme University Hospital
    ClinicalTrials.gov Identifier:
    NCT06143410
    Other Study ID Numbers:
    • SRB2023309
    First Posted:
    Nov 22, 2023
    Last Update Posted:
    Nov 29, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lidocaine
    Propofol
    Pharmaceutical Solutions

    Study Results

    No Results Posted as of Nov 29, 2023