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

NCT06143410 | Unknown

• 1 other identifier: SRB2023309
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diagnostic Gastroscopy

Outcome Measures

Primary Outcomes (1)

• ED50 of propofol

  ED50 of propofol for gastroscope introduction without movements

  gastroscope introduction

Secondary Outcomes (11)

• number of participants with moderate hypoxemia

  Procedure (during propofol sedation and gastroscopy)

• number of participants with hypotension

  Procedure (during propofol sedation and gastroscopy

• number of participants presenting cough

  Procedure (during propofol sedation and gastroscopy)

• number of participants presenting laryngospasm

  Procedure (during propofol sedation and gastroscopy)

• number of participants presenting involuntary movements

  Procedure (during propofol sedation and gastroscopy)

Study Arms (2)

Linisol

ACTIVE COMPARATOR

Patients will receive 1.5 mg/kg of intravenous linisol before propofol sedatation and gastroscope introduction

Drug: Lidocaine 2% Injectable Solution; Drug: Propofol injection; Procedure: gastroscopy

Control

PLACEBO COMPARATOR

Patients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction

Drug: Saline administration as placebo; Drug: Propofol injection; Procedure: gastroscopy

Interventions

Lidocaine 2% Injectable Solution DRUG

administration of a bolus of lidocaine 1.5 mg/kg

Linisol

Saline administration as placebo DRUG

administration of a bolus of saline solution as a placebo

Also known as: administration of a bolus of saline solution as a placebo

Control

Propofol injection DRUG

Sedation by total intravenous administration (TIVA) of propofol using target controlled infusion (TCI)

Control; Linisol

gastroscopy PROCEDURE

esogastroduodenoscopy

Control; Linisol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for gastroscopy under narcosis and who have signed the consent.
• ASA score: 1 and 2
• BMI between 18 and 30 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Boudart Céline

Brussels, 1070, Belgium

RECRUITING

MeSH Terms

Interventions

Lidocaine; Propofol; Gastroscopy

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Céline Boudart, PhD

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Céline Boudart, PhD

CONTACT

+322555391+9; celine.boudart@hubruxelles.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: computered randomisation, sealed enveloppes linisol versus placebo prepared by anesthesist not involved in the study or in patient care
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: April 8, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: April 24, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after publication
• Access Criteria: data will be provided anonymously upon request by email from the corresponding author

Locations

BE (1)