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

Phase 4

Completed

• Conditions: Tolerance
• Interventions: Drug: Lidocaine; Drug: Placebo

• Registration Number: NCT02733471
• Lead Sponsor: Basque Health Service

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-02
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-11
• Primary Completion: 2017-04
• Study Completion: 2017-05
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-26
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 586

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine	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.
Control	Placebo	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

Primary Outcome Measures

Name	Time	Method
Degree of tolerance referred by the endoscopist in each group.	Up to 15 minutes after endoscopy	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Araba University Hospital; 🇪🇸 Vitoria, Alava, Spain