Usefulness of Lidocaine as Topical Pharyngeal Anaesthesia in Esophagogastroduodenoscopy Under Sedation With Propofol

NCT01489891 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-03-08

Study results available
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Summary

The purpose of this study is to determine the efficacy of application of the anaesthesia topical pharyngeal with lidocaine in esophagogastroduodenoscopy under propofol´s sedation, in therms of dosage and side effect´s reduction overall.

Conditions

  • Esophagogastroduodenoscopy

Interventions

DRUG

Lidocaine

Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff).

DRUG

Placebo

Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking).

Sponsors & Collaborators

  • Hospital Universitario Infanta Cristina

    lead OTHER

Principal Investigators

  • Felipe de la Morena, M.D.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-07-31
Completion
2012-08-31

Countries

  • Spain

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01489891 on ClinicalTrials.gov