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

Basque Health Service586 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

586

Conditions

Tolerance

Interventions

LidocaineDRUG

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Araba University Hospital

Vitoria-Gasteiz, Alava, Spain

Outcomes

Primary Outcomes

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)