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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014