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

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ClinicalTrials.gov Identifier: NCT01489891
Recruitment Status : Completed
First Posted : December 12, 2011
Results First Posted : March 8, 2013
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
Felipe de la Morena Lopez MD, Hospital Universitario Infanta Cristina

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Esophagogastroduodenoscopy Drug: Lidocaine Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Usefulness of Applying Lidocaine as Topical Pharyngeal Anaesthesia in Esophagogastroduodenoscopies Performed Under Sedation With Propofol- a Randomized Controlled Trial
Study Start Date : December 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : August 2012

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Lidocaine group
Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD)
 Drug: Lidocaine
Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff).
Placebo Comparator: Placebo
Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.
 Drug: Placebo
Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking).


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy [ Time Frame: 8 months ]
    The propofol will be administered by an expert anaesthetist in repeated bolus (10-20 mg each 30-60 seconds) after an initial induction dosage (0.5-0.6 mg/kg ASA (American Society of Anaesthesiologists) I-II or 0.25-0.35 mg/kg ASA III-IV) to obtain an uniform level of sedation (OAAS 3 and bispectral index (BIS) 70-80) and adequate perceived patient tolerance (no gag-reflex, cough, sudden movements).


Secondary Outcome Measures :
  1. Percentage of Participants With Adverse Events in Both Groups [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 hours postprocedure ]
    Hypoxemia (SatO2<90% or >4% if the baseline was under 93%), bradycardia (<60 bpm or >10% from baseline), hypotension (systolic blood pressure under 90 mmHg and/or diastolic 60 mmHg), anaphylactic reaction, aspiration o methaemoglobinemia.

  2. Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist [ Time Frame: 8 months ]
    Define as easiness to reach the expected objectives for endoscopy without patient interference: very satisfied, satisfied, neutral, unsatisfied.

  3. Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist [ Time Frame: 8 months ]
    Define as easiness to reach and maintain the level of sedation and patient comfort during endoscopy: very satisfied, satisfied, neutral, unsatisfied.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489891


Locations
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Spain
Hospital Universitario Infanta Cristina
Parla, Madrid, Spain, 28980
Sponsors and Collaborators
Hospital Universitario Infanta Cristina
Investigators
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Principal Investigator: Felipe de la Morena, M.D.
More Information
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Publications of Results:

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Responsible Party: Felipe de la Morena Lopez MD, Gastroenterologist. Head of endoscopy, Hospital Universitario Infanta Cristina
ClinicalTrials.gov Identifier: NCT01489891    
Other Study ID Numbers: 2011-005704-15
ATF-EGD001
First Posted: December 12, 2011    Key Record Dates
Results First Posted: March 8, 2013
Last Update Posted: March 8, 2013
Last Verified: March 2013
Keywords provided by Felipe de la Morena Lopez MD, Hospital Universitario Infanta Cristina:
Esophagogastroduodenoscopy
Lidocaine
Propofol
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action