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

Information source: Hospital Universitario Infanta Cristina
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Esophagogastroduodenoscopy

Intervention: Lidocaine (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hospital Universitario Infanta Cristina

Official(s) and/or principal investigator(s):
Felipe de la Morena, M.D., Principal Investigator


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.

Clinical Details

Official title: Usefulness of Applying Lidocaine as Topical Pharyngeal Anaesthesia in Esophagogastroduodenoscopies Performed Under Sedation With Propofol- a Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy

Secondary outcome:

Percentage of Participants With Adverse Events in Both Groups

Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist

Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Patient´s over 18 years old that received standard indication for sedated

esophagogastroduodenoscopy (American Society of Gastrointestinal Endoscopy Guidelines) in our centre between the period of study. Exclusion Criteria:

- Patients under 18 years old

- Unable to obtain inform´s consent

- Emergency endoscopy

- Pregnant women

- Encephalopathy

- Well known allergic reaction to propofol, amide-anaesthesics, soy or eggs

- Methaemoglobinemia induced factor risks

- No previous or unknown fasting

Locations and Contacts

Hospital Universitario Infanta Cristina, Parla, Madrid 28980, Spain
Additional Information

Starting date: December 2011
Last updated: March 7, 2013

Page last updated: August 23, 2015

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