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

Hospital Universitario Infanta Cristina120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

120

Conditions

Esophagogastroduodenoscopy

Interventions

LidocaineDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hospital Universitario Infanta Cristina

Parla, Madrid, Spain

Outcomes

Primary Outcomes

Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy

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).

Time frame: 8 months

Secondary Outcomes

Percentage of Participants With Adverse Events in Both Groups

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.

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 hours postprocedure

Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist

Define as easiness to reach the expected objectives for endoscopy without patient interference: very satisfied, satisfied, neutral, unsatisfied.

Time frame: 8 months

Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist

Define as easiness to reach and maintain the level of sedation and patient comfort during endoscopy: very satisfied, satisfied, neutral, unsatisfied.

Time frame: 8 months

Data from ClinicalTrials.gov

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