Intravenous Lidocaine to Reduce Propofol Consumption During Gastroscopy.

Does Intravenous Lidocaine Reduce Propofol Consumption and the Side Effects of Sedation During Gastroscopy in ASA 1 and 2 Patients.

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 Overview

• Status: Completed
• Conditions: Diagnostic Gastroscopy
• Intervention / Treatment: Drug: Lidocaine 2% Injectable Solution; Drug: Propofol injection; Procedure: gastroscopy; Drug: Saline administration as placebo

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1070
    • Erasme Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Linisol; Patients will receive 1.5 mg/kg of intravenous linisol before propofol sedatation and gastroscope introduction	Drug: Lidocaine 2% Injectable Solution; administration of a bolus of lidocaine 1.5 mg/kg; Drug: Propofol injection; Sedation by total intravenous administration (TIVA) of propofol; Procedure: gastroscopy; esogastroduodenoscopy
Placebo Comparator: Sham; Patients will receive intravenous placebo (saline solution),before propofol sedation and gastroscope introduction	Drug: Propofol injection; Sedation by total intravenous administration (TIVA) of propofol; Procedure: gastroscopy; esogastroduodenoscopy; Drug: Saline administration as placebo; administration of a bolus of saline solution as a placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total propofol dose in milligramme	total propofol dose consumed	procedure (from the beginning of propofol infusion until arrival of the gastroscope in the stomach)
total propofol dose in milligramme	total propofol dose consumed	Procedure (from the beginning of propofol infusion until endoscope removal)
propofol in site effet concentration in microgram per milliliter	AIVOC : Effect concentration of propofol	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	Procedure (from the beginning of propofol infusion until endoscope removal)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participants with moderate hypoxemia	pulse saturation below 95%	Procedure (during propofol sedation and gastroscopy)
number of participants with hypotension	mean arterial pressure below 65 mmHg	Procedure (during propofol sedation and gastroscopy)
number of participants with severe hypoxemia	pulse saturation below 90%	Procedure (during propofol sedation and gastroscopy)
number of participants presenting cough	cough suggesting to light sedation	Procedure (during propofol sedation and gastroscopy)
number of participants presenting laryngospasm	laryngospasm suggesting to light sedation	Procedure (during propofol sedation and gastroscopy)
number of participants presenting involuntary movements	involuntary movements suggesting to light sedation	Procedure (during propofol sedation and gastroscopy)
number of participants presenting side effects of lidocaine administration	metallic taste, tinnitus, anaphylaxis	during gastroscopy procedure
score of Endoscopist satisfaction (1-5)	Endoscopist satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent	completed procedure (before transfer to recovery room)
score of Patient satisfaction (1-5)	Patient satisfaction :1 = very bad; 2=bas; 3=good; 4=very good; 5= excellent	at recovery room discharge, an average of 1 hour after completed procedure
throat pain	analog digital scale from 1 to 10	at recovery room discharge, an average of 1 hour after completed procedure

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Principal Investigator: celine Boudart, MD PhD, Erasme University Hospital

Publications and helpful links

General Publications

• Qi XR, Sun JY, An LX, Zhang K, Xue FS. Effects of intravenous lidocaine on hypoxemia induced by propofol-based sedation for gastrointestinal endoscopy procedures: study protocol for a prospective, randomized, controlled trial. Trials. 2022 Sep 24;23(1):800. doi: 10.1186/s13063-022-06719-6.
• Qi XR, Sun JY, An LX, Zhang K. Effect of intravenous lidocaine on the ED50 of propofol for inserting gastroscope without body movement in adult patients: a randomized, controlled study. BMC Anesthesiol. 2022 Oct 17;22(1):319. doi: 10.1186/s12871-022-01861-9.
• Hu S, Wang M, Li S, Zhou W, Zhang Y, Shi H, Ye P, Sun J, Liu F, Zhang W, Zheng L, Hou Q, Wang Y, Sun W, Chen Y, Lu Z, Ji Z, Liao L, Lv X, Wang Y, Wang X, Yang H. Intravenous Lidocaine Significantly Reduces the Propofol Dose in Elderly Patients Undergoing Gastroscopy: A Randomized Controlled Trial. Drug Des Devel Ther. 2022 Aug 12;16:2695-2705. doi: 10.2147/DDDT.S377237. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2023
• Primary Completion (Actual): August 21, 2023
• Study Completion (Actual): August 25, 2023

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Propofol; Lidocaine
• Other Study ID Numbers: P2023/236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No