Evaluation of the efficacy and safety of administering lidocaine spray in gastroscopies: A randomized clinical trial.

Phase 1

• Conditions: Elective gastroscopy; MedDRA version: 18.0 Level: LLT Classification code 10018047 Term: Gastroscopy System Organ Class: 100000004848; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-000923-10-ES
• Lead Sponsor: BASQUE HEALTH SYSTEM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-25
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 552

Inclusion Criteria

-Patients aged over 18
-ASA I, II and III
-Non allergic to lidocaine or any of the drugs used in the study
-Conset form signed by the patient
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52

Exclusion Criteria

-Pregnancy or lactation
-Patients aged over 70
-Poorly controlled insulin-treated type I or II diabetes (Hb1Ac=8).
-Moderate to severe liver disease
-Moderate to severe renal insufficiency
-Moderate to severe Obstructive Sleep Apnea Syndrome (OSA) (AHI=15).
-Severe respiratory insufficiency
-Open angle glaucoma
-Patients with encephalopaty
-Patients with medical history of methemoglobinemia
-Patients with history of drug or alcohol abuse

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified