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Completed

NCT Number: NCT02733471

Evaluation of the Efficacy and Safety of Administering Lidocaine Spray in Oesophago-gastro-duodenoscopy

This study evaluates the efficacy and safety of the administration of lidocaine spray in oesophago-gastro-duodenoscopies. Half of the patients will receive lidocaine spray, while the other half will receive a placebo.

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Key information

Conditions

Tolerance

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Araba University Hospital

Vitoria-Gasteiz, Alava, 01009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged over 18
  • ASA I, II and III
  • Non allergic to lidocaine or any of the drugs used in the study
  • Consent form signed by the patient

Exclusion criteria

  • Stomach or esophagus diagnosed cancer
  • Giant hiatal hernia diagnosed
  • Zenker's diverticulum diagnosed
  • Achalasia diagnosed
  • Patients aged over 70
  • Medical history of moderate to severe liver disease
  • Medical history of moderate to severe renal insufficiency
  • Medical history of moderate to severe Obstructive Sleep Apnea Syndrome (OSA) (AHI≥15).
  • Severe respiratory insufficiency(asmtha or COPD) diagnosed
  • Patients with encephalopaty active
  • Patients with medical history of methemoglobinemia
  • Patients with history of drug abuse
  • Patients with mental impairment
  • Patients with BMI≥ 35
  • Use of pediatric tube

Treatment and study plan

Lidocaine

Drug

Placebo

Drug

Placebo

Primary outcomes

  1. Degree of tolerance referred by the endoscopist in each group.

    Time frame: Up to 15 minutes after endoscopy

    Establish degree of tolerance referred by the endoscopist in each group according to the scale defined by Leich et al ( Gastrointestinal Endosc 1993;39:384-7)

Secondary outcomes

  1. Degree of tolerance referred by the patient in each group

    Time frame: Up to 15 minutes after endoscopy

    Establish degree of tolerance referred by the patient in each group according to the scale defined by Leich et al

  2. Endoscopist's level of satisfaction with the procedure in each group

    Time frame: Up to 15 minutes after endoscopy

    Endoscopist's level of satisfaction with the procedure according to a visual analogic scale

  3. Patient's level of satisfaction with the procedure in each group.

    Time frame: Up to 15 minutes after endoscopy

    Patient's level of satisfaction with the procedure according to a visual analogic scale

  4. Number of completed procedures in control and lidocaine group

    Time frame: Up to 15 minutes after endoscopy

    Number of completed procedures

  5. Estimate the total dose of propofol used in each group

    Time frame: 15 minutes before endoscopy

    Dose of propofol used

  6. Establish and compare the number of adverse events detected in control and lidocaine group

    Time frame: Up to 15 minutes after endoscopy

    Number of adverse events

  7. Estimate the number of patients with retrograde amnesia in each group

    Time frame: Up to 15 minutes after endoscopy

    Number of patients referring retrograde amnesia

  8. Estimate the number of patients with cough in each group

    Time frame: Up to 15 minutes after endoscopy

    Cough referred by the patient

  9. Estimate the number of patients with oropharyngeal discomfort in each group.

    Time frame: Up to 15 minutes after endoscopy

    Oropharyngeal discomfort referred by the patient

Sponsors and collaborators

Lead sponsor

Basque Health Service

Other Gov

Registry information

Acronym: LIDOGTC

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 11, 2016
Registry last updated
Jan 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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