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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Efficacy and Safety of Administering Lidocaine Spray in Oesophago-gastro-duodenoscopy

Conditions
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Tolerance

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br>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<br> <br> |
| Placebo Comparator: Control<br>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<br>* Placebo<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lidocaine, Endoscopy, Tolerance