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

Study Overview
=================
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.

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

Conditions
-----------------
Diagnostic Gastroscopy

Intervention / Treatment
-----------------
* Drug: Lidocaine 2% Injectable Solution
* Drug: Saline administration as placebo
* Drug: Propofol injection
* Procedure: gastroscopy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 with hypotension | mean arterial pressure below 65 mmHg | 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) | 
| number of participants presenting side effects of lidocaine administration | metallic taste, tinnitus, anaphylaxis | 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 | 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 | 
| 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 |