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

Tolerance Clinical Trial

— LIDOGTC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733471
• Other study ID #: LIDOGTC
• Status: Completed
• Phase: Phase 4
• First received: March 2, 2016
• Last updated: January 26, 2018
• Start date: April 2016
• Est. completion date: May 2017

Study information

• Verified date: January 2018
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 586
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Tolerance

Intervention

Drug:
• Lidocaine

• Placebo
Placebo

Locations

Country	Name	City	State
Spain	Araba University Hospital	Vitoria	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

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