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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Felipe de la Morena Lopez MD, Hospital Universitario Infanta Cristina
ClinicalTrials.gov Identifier:
NCT01489891
First received: December 3, 2011
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Esophagogastroduodenoscopy
Drug: Lidocaine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Infanta Cristina:

Primary Outcome Measures:
  • Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Define as easiness to reach the expected objectives for endoscopy without patient interference: very satisfied, satisfied, neutral, unsatisfied.

  • Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Define as easiness to reach and maintain the level of sedation and patient comfort during endoscopy: very satisfied, satisfied, neutral, unsatisfied.


Enrollment: 120
Study Start Date: December 2011
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489891

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

Publications:

Responsible Party: Felipe de la Morena Lopez MD, Gastroenterologist. Head of endoscopy, Hospital Universitario Infanta Cristina
ClinicalTrials.gov Identifier: NCT01489891     History of Changes
Other Study ID Numbers: 2011-005704-15, ATF-EGD001
Study First Received: December 3, 2011
Results First Received: October 29, 2012
Last Updated: March 7, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Universitario Infanta Cristina:
Esophagogastroduodenoscopy
Lidocaine
Propofol

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on April 16, 2014