Evaluation of the Efficacy and Safety of Administering Lidocaine Spray in Oesophago-gastro-duodenoscopy (LIDOGTC)

This study evaluates the efficacy and safety of the administration of lidocaine spray in oesophago-gastro-duodenoscopies. Half of the patients will receive lidocaine spray, while the other half will receive a placebo.

Study Overview

• Status: Completed
• Conditions: Tolerance
• Intervention / Treatment: Drug: Placebo; Drug: Lidocaine

• Study Type: Interventional
• Enrollment (Actual): 586
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Alava
    • Vitoria, Alava, Spain, 01009
      • Araba University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Patients aged over 18
• ASA I, II and III
• Non allergic to lidocaine or any of the drugs used in the study
• Consent form signed by the patient

Exclusion Criteria:

• Stomach or esophagus diagnosed cancer
• Giant hiatal hernia diagnosed
• Zenker's diverticulum diagnosed
• Achalasia diagnosed
• Patients aged over 70
• Medical history of moderate to severe liver disease
• Medical history of moderate to severe renal insufficiency
• Medical history of moderate to severe Obstructive Sleep Apnea Syndrome (OSA) (AHI≥15).
• Severe respiratory insufficiency(asmtha or COPD) diagnosed
• Patients with encephalopaty active
• Patients with medical history of methemoglobinemia
• Patients with history of drug abuse
• Patients with mental impairment
• Patients with BMI≥ 35
• Use of pediatric tube

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine; Five lidocaine solution puffs (10mg lidocaine/puff) on the four posterior quadrants of the pharynx and on the base of the tongue, 3 minutes before the oesophago-gastro-duodenoscopy.	Drug: Lidocaine
Placebo Comparator: Control; Five placebo solution puffs on the four posterior quadrants of the pharynx and on the base of the tongue, 3 minutes before the oesophago-gastro-duodenoscopy	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of tolerance referred by the endoscopist in each group.	Establish degree of tolerance referred by the endoscopist in each group according to the scale defined by Leich et al ( Gastrointestinal Endosc 1993;39:384-7)	Up to 15 minutes after endoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of tolerance referred by the patient in each group	Establish degree of tolerance referred by the patient in each group according to the scale defined by Leich et al	Up to 15 minutes after endoscopy
Endoscopist's level of satisfaction with the procedure in each group	Endoscopist's level of satisfaction with the procedure according to a visual analogic scale	Up to 15 minutes after endoscopy
Patient's level of satisfaction with the procedure in each group.	Patient's level of satisfaction with the procedure according to a visual analogic scale	Up to 15 minutes after endoscopy
Number of completed procedures in control and lidocaine group	Number of completed procedures	Up to 15 minutes after endoscopy
Estimate the total dose of propofol used in each group	Dose of propofol used	15 minutes before endoscopy
Establish and compare the number of adverse events detected in control and lidocaine group	Number of adverse events	Up to 15 minutes after endoscopy
Estimate the number of patients with retrograde amnesia in each group	Number of patients referring retrograde amnesia	Up to 15 minutes after endoscopy
Estimate the number of patients with cough in each group	Cough referred by the patient	Up to 15 minutes after endoscopy
Estimate the number of patients with oropharyngeal discomfort in each group.	Oropharyngeal discomfort referred by the patient	Up to 15 minutes after endoscopy

Collaborators and Investigators

• Sponsor: Basque Health Service
• Investigators: Principal Investigator: Irene Martin Marcos, RN, Basque health System

Publications and helpful links

General Publications

• Martin-Marcos I, Fernandez-Morte N, Balsategui-Martin M, Ortiz-Cantero A, Bermudez-Ampudia C, Lopez-Picado A, Perez-Vaquero P, Salvador-Perez M, Cristobal-Dominguez E. Evaluation of pharyngeal lidocaine anesthesia for esophagogastroduodenoscopy: Double-blind randomized control trial. Dig Endosc. 2022 May;34(4):808-815. doi: 10.1111/den.14168. Epub 2021 Nov 17.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (Estimate): April 11, 2016

Study Record Updates

• Last Update Posted (Actual): January 29, 2018
• Last Update Submitted That Met QC Criteria: January 26, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Tolerance; Endoscopy; Lidocaine
• 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; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: LIDOGTC

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