Intravenous Lidocaine to Reduce Propofol Consumption During Gastroscopy.

NCT05944887 | Completed

• 1 other identifier: P2023/236
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Conditions

Diagnostic Gastroscopy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• 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 with severe hypoxemia

  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)

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

Sham

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

Sham

Propofol injection DRUG

Sedation by total intravenous administration (TIVA) of propofol

Linisol; Sham

gastroscopy PROCEDURE

esogastroduodenoscopy

Linisol; Sham

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)

Erasme Hospital

Brussels, 1070, Belgium

Location

Related Publications (3)

• 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.

  PMID: 36153625 BACKGROUND

• 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.

  PMID: 36253717 BACKGROUND

• 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.

  PMID: 35983429 BACKGROUND

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

• celine Boudart, MD PhD

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 13, 2023
• Study Start: July 21, 2023
• Primary Completion: August 21, 2023
• Study Completion: August 25, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

BE (1)