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

Basque Health Service

Status and phase: Completed; Phase 4

Conditions: Tolerance

Treatments: Drug: Placebo; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02733471

LIDOGTC

Details and patient eligibility

About

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.

Enrollment: 586 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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586 participants in 2 patient groups, including a placebo group

Lidocaine

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo