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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

586 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-05-31

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.

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Detailed Description

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Conditions

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Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Lidocaine

Intervention Type DRUG

Placebo

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No