Intravenous Lidocaine to Reduce Propofol Consumption During Gastroscopy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-21

Study Completion Date

2023-08-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lidocaine Infusion for Propofol Dose Reduction in ERCP Procedure

NCT05274984

Sedation

UNKNOWN PHASE1

Protocol for Eslax Intravenous Drug Use Investigation (Study P06082)

NCT00902070

Anesthesia

COMPLETED

Evaluation of the Benefit of Lidocaine on the Prevention of the Risk of Post Endoscopic Retrograde Cholangio-pancreatography Pancreatitis.

NCT05667987

ERCP Surgery

RECRUITING NA

Perioperative Lignocaine and Sleep Disturbance

NCT03317912

Sleep Disturbance

UNKNOWN PHASE4

Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy

NCT03038958

Knee Arthroscopy Spinal Anesthesia

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diagnostic Gastroscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

computered randomisation, sealed enveloppes linisol versus placebo prepared by anesthesist not involved in the study or in patient care

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Linisol

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

Group Type ACTIVE_COMPARATOR

Lidocaine 2% Injectable Solution

Intervention Type DRUG

administration of a bolus of lidocaine 1.5 mg/kg

Propofol injection

Intervention Type DRUG

Sedation by total intravenous administration (TIVA) of propofol

gastroscopy

Intervention Type PROCEDURE

esogastroduodenoscopy

Sham

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

Group Type PLACEBO_COMPARATOR

Saline administration as placebo

Intervention Type DRUG

administration of a bolus of saline solution as a placebo

Propofol injection

Intervention Type DRUG

Sedation by total intravenous administration (TIVA) of propofol

gastroscopy

Intervention Type PROCEDURE

esogastroduodenoscopy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lidocaine 2% Injectable Solution

administration of a bolus of lidocaine 1.5 mg/kg

Intervention Type DRUG

Saline administration as placebo

administration of a bolus of saline solution as a placebo

Intervention Type DRUG

Propofol injection

Sedation by total intravenous administration (TIVA) of propofol

Intervention Type DRUG

gastroscopy

esogastroduodenoscopy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No