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

Not Applicable

Recruiting

• Conditions: Diagnostic Gastroscopy
• Interventions: Drug: Lidocaine 2% Injectable Solution; Drug: Saline administration as placebo; Drug: Propofol injection; Procedure: gastroscopy

• Registration Number: NCT06143410
• Lead 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-16
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-22
• Study Start: 2024-04-08
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Linisol	Lidocaine 2% Injectable Solution	Patients will receive 1.5 mg/kg of intravenous linisol before propofol sedatation and gastroscope introduction
Linisol	Propofol injection	Patients will receive 1.5 mg/kg of intravenous linisol before propofol sedatation and gastroscope introduction
Linisol	gastroscopy	Patients will receive 1.5 mg/kg of intravenous linisol before propofol sedatation and gastroscope introduction
Control	Saline administration as placebo	Patients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction
Control	Propofol injection	Patients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction
Control	gastroscopy	Patients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction

Primary Outcome Measures

Name	Time	Method
ED50 of propofol	gastroscope introduction	ED50 of propofol for gastroscope introduction without movements

Secondary Outcome Measures

Name	Time	Method
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
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
throat pain	at recovery room discharge, an average of 1 hour after completed procedure	analog digital scale from 1 to 10
number of participants with hypotension	Procedure (during propofol sedation and gastroscopy	mean arterial pressure below 65 mmHg
number of participants with moderate hypoxemia	Procedure (during propofol sedation and gastroscopy)	pulse saturation below 95%
number of participants presenting cough	Procedure (during propofol sedation and gastroscopy)	cough suggesting to light sedation
number of participants presenting involuntary movements	Procedure (during propofol sedation and gastroscopy)	involuntary movements suggesting to light sedation
number of participants presenting side effects of lidocaine administration	Time Frame: during gastroscopy procedure	metallic taste, tinnitus, anaphylaxis
number of participants presenting laryngospasm	Procedure (during propofol sedation and gastroscopy)	laryngospasm suggesting to light sedation
Time to anesthesia recover	completed procedure (before transfer to recovery room)	Time between stopping Propofol and recovering a MOAA/S score ≥ 4
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)

Trial Locations

Locations (1)

Boudart Céline; 🇧🇪 Bruxelles, Belgium