Clinical trial NCT06143410: Intravenous Lidocaine to Reduce ED50 for Propofol Administered Using Target Controlled Infusion (TCI) During Gastroscopy
Official title: Does Intravenous Lidocaine Reduce ED 50 for Propofol Administered Using Target Controlled Infusion (TCI) During Gastroscopy in ASA 1 and 2 Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diagnostic Gastroscopy
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: ED50 of propofol
timeFrame: gastroscope introduction
Secondary outcomes:
measure: number of participants with moderate hypoxemia
timeFrame: Procedure (during propofol sedation and gastroscopy)
measure: number of participants with hypotension
timeFrame: Procedure (during propofol sedation and gastroscopy
measure: number of participants presenting cough
timeFrame: Procedure (during propofol sedation and gastroscopy)
measure: number of participants presenting laryngospasm
timeFrame: Procedure (during propofol sedation and gastroscopy)
measure: number of participants presenting involuntary movements
timeFrame: Procedure (during propofol sedation and gastroscopy)
measure: number of participants presenting side effects of lidocaine administration
timeFrame: Time Frame: during gastroscopy procedure
measure: score of Endoscopist satisfaction (1-5)
timeFrame: completed procedure (before transfer to recovery room)
measure: score of Patient satisfaction (1-5)
timeFrame: at recovery room discharge, an average of 1 hour after completed procedure
measure: throat pain
timeFrame: at recovery room discharge, an average of 1 hour after completed procedure
measure: Time to anesthesia recover
timeFrame: completed procedure (before transfer to recovery room)
measure: Time for post anesthesic care unit discharge
timeFrame: at recovery room discharge, an average of 1 hour after completed procedure
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Boudart Céline
Study officials:
affiliation: Erasme hospital
name: Céline Boudart, PhD
role: PRINCIPAL_INVESTIGATOR
References: