Intravenous Lidocaine to Reduce Propofol Consumption During Gastroscopy.

Erasme University Hospital46 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Diagnostic Gastroscopy

Interventions

Lidocaine 2% Injectable SolutionDRUG

administration of a bolus of lidocaine 1.5 mg/kg

Saline administration as placeboDRUG

administration of a bolus of saline solution as a placebo

Propofol injectionDRUG

Sedation by total intravenous administration (TIVA) of propofol

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Erasme Hospital

Brussels, Belgium

Outcomes

Primary Outcomes

total propofol dose in milligramme

total propofol dose consumed

Time frame: procedure (from the beginning of propofol infusion until arrival of the gastroscope in the stomach)

total propofol dose in milligramme

total propofol dose consumed

Time frame: Procedure (from the beginning of propofol infusion until endoscope removal)

propofol in site effet concentration in microgram per milliliter

AIVOC : Effect concentration of propofol

Time frame: procedure (from the beginning of propofol infusion until arrival of the gastroscope in the stomach)

propofol in site effet concentration in microgram per milliliter

AIVOC : Effect concentration of propofol

Time frame: Procedure (from the beginning of propofol infusion until endoscope removal)

Secondary Outcomes

number of participants with moderate hypoxemia

pulse saturation below 95%

Time frame: Procedure (during propofol sedation and gastroscopy)

number of participants with hypotension

mean arterial pressure below 65 mmHg

Time frame: Procedure (during propofol sedation and gastroscopy)

number of participants with severe hypoxemia

pulse saturation below 90%

Time frame: Procedure (during propofol sedation and gastroscopy)

number of participants presenting cough

Data from ClinicalTrials.gov

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