Intravenous Lidocaine to Reduce Propofol Consumption During Gastroscopy.

Not Applicable

Completed

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

• Registration Number: NCT05944887
• Lead Sponsor: Erasme University Hospital

Brief Summary

The goal of this clinical trial is to assess if intravenous administration of linisol reduce the propofol consumption and the sides effects of sedation 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.

After the gastroscopy, patients will be asked to complete a satisfaction questionnaire

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-19
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-13
• Study Start: 2023-07-21
• Primary Completion: 2023-08-21
• Study Completion: 2023-08-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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
Sham	Saline administration as placebo	Patients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction
Sham	Propofol injection	Patients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction
Sham	gastroscopy	Patients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction

Primary Outcome Measures

Name	Time	Method
total propofol dose in milligramme	Procedure (from the beginning of propofol infusion until endoscope removal)	total propofol dose consumed
propofol in site effet concentration in microgram per milliliter	Procedure (from the beginning of propofol infusion until endoscope removal)	AIVOC : Effect concentration of propofol

Secondary Outcome Measures

Name	Time	Method
number of participants with hypotension	Procedure (during propofol sedation and gastroscopy)	mean arterial pressure below 65 mmHg
number of participants with severe hypoxemia	Procedure (during propofol sedation and gastroscopy)	pulse saturation below 90%
number of participants presenting cough	Procedure (during propofol sedation and gastroscopy)	cough suggesting to light sedation
number of participants with moderate hypoxemia	Procedure (during propofol sedation and gastroscopy)	pulse saturation below 95%
number of participants presenting side effects of lidocaine administration	during gastroscopy procedure	metallic taste, tinnitus, anaphylaxis
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
number of participants presenting laryngospasm	Procedure (during propofol sedation and gastroscopy)	laryngospasm suggesting to light sedation
number of participants presenting involuntary movements	Procedure (during propofol sedation and gastroscopy)	involuntary movements suggesting to light sedation
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

Trial Locations

Locations (1)

Erasme Hospital; 🇧🇪 Brussel, Belgium