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
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.
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 GroupsLikert Four Elements Scale to Evaluate the Satisfaction of Endoscopist Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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