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

Phase 4

Completed

• Conditions: Esophagogastroduodenoscopy
• Interventions: Drug: Placebo; Drug: Lidocaine

• Registration Number: NCT01489891
• Lead Sponsor: Hospital Universitario Infanta Cristina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-03
• Study First Submitted QC: 2011-12-08
• Study First Posted: 2011-12-12
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Results First Submitted: 2012-10-29
• Status Verified: 2013-03
• Results First Submitted QC: 2013-03-07
• Last Update Submitted: 2013-03-07
• Results First Posted: 2013-03-08
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.
Lidocaine group	Lidocaine	Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD)

Primary Outcome Measures

Name	Time	Method
Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy	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 Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events in Both Groups	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.
Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist	8 months	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	8 months	Define as easiness to reach and maintain the level of sedation and patient comfort during endoscopy: very satisfied, satisfied, neutral, unsatisfied.

Trial Locations

Locations (1)

Hospital Universitario Infanta Cristina; 🇪🇸 Parla, Madrid, Spain