Trial intelligence / Profile preview

Lidocaine spray in oesophago-gastro-duodenoscopy

NCT02733471Phase 4

Key facts

Status: Completed
Start: Apr 2016
Primary completion: Apr 2017
Countries: 1
Sponsor: Osakidetza
Modality: Small Molecules

Drugs: lidocaine

Overview

Phase 4, randomised, double-blind trial of lidocaine (2 arms), sponsored by Osakidetza. Primary endpoint: Degree of tolerance referred by the endoscopist. Started Apr 2016; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Lidocaine
Five lidocaine solution puffs (10mg/puff) on the pharynx and tongue base.
Control
Five placebo solution puffs on the pharynx and tongue base.

Who it enrols

Adult patients (18-70 years) with ASA I-III undergoing oesophago-gastro-duodenoscopy, excluding those with specific esophageal/gastric conditions, severe organ insufficiency, or BMI >= 35.

Endpoints

Primary

Degree of tolerance referred by the endoscopistUp to 15 minutes after endoscopy

Secondary

Degree of tolerance referred by the patientUp to 15 minutes after endoscopy
Endoscopist's level of satisfaction with the procedureUp to 15 minutes after endoscopy
Patient's level of satisfaction with the procedureUp to 15 minutes after endoscopy
Number of completed proceduresUp to 15 minutes after endoscopy
Total dose of propofol used15 minutes before endoscopy
Number of adverse events detectedUp to 15 minutes after endoscopy
Number of patients with retrograde amnesiaUp to 15 minutes after endoscopy
Number of patients with coughUp to 15 minutes after endoscopy

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