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Completed

NCT Number: NCT01489891

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

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.

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Key information

Conditions

Esophagogastroduodenoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario Infanta Cristina

Parla, Madrid, 28980, Spain

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Lidocaine

Drug

Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff).

Placebo

Drug

Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking).

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Infanta Cristina

Other

Registry information

Official study title

Usefulness of Applying Lidocaine as Topical Pharyngeal Anaesthesia in Esophagogastroduodenoscopies Performed Under Sedation With Propofol- a Randomized Controlled Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 12, 2011
Registry last updated
Mar 8, 2013

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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