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NCT06143410 | RECRUITING | Diagnostic Gastroscopy


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

Erasme University Hospital

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

Diagnostic Gastroscopy

Intervention/treatment

Lidocaine 2% Injectable Solution

Saline administration as placebo

Propofol injection

gastroscopy

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : QUADRUPLE
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.
Actual Study Start Date : 2024-04-08
Estimated Primary Completion Date : 2024-08-31
Estimated Study Completion Date : 2024-08-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

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

Location Details

NCT06143410


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Locations


RECRUITING

Belgium,

BOUDART Céline

Bruxelles, Belgium, 1070

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