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

• 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.

• Number 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 preasure under 90 mmHg and/or dyastolic 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 objetives 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.

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.

• Drug: Lidocaine
  Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff).
• Drug: Placebo
  Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking).

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

• Jiménez-Puente G, Hidalgo-Isla M. [Use of topical pharyngeal anaesthesia in esophagogastroduodenoscopy in unsedated patients]. Enferm Clin. 2011 Jan-Feb;21(1):30-4. Epub 2011 Feb 18. Spanish.
• Amornyotin S, Srikureja W, Chalayonnavin W, Kongphlay S, Chatchawankitkul S. Topical viscous lidocaine solution versus lidocaine spray for pharyngeal anesthesia in unsedated esophagogastroduodenoscopy. Endoscopy. 2009 Jul;41(7):581-6. Epub 2009 Jul 8.
• Evans LT, Saberi S, Kim HM, Elta GH, Schoenfeld P. Pharyngeal anesthesia during sedated EGDs: is "the spray" beneficial? A meta-analysis and systematic review. Gastrointest Endosc. 2006 May;63(6):761-6. Review.
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• Mulcahy HE, Greaves RR, Ballinger A, Patchett SE, Riches A, Fairclough PD, Farthing MJ. A double-blind randomized trial of low-dose versus high-dose topical anaesthesia in unsedated upper gastrointestinal endoscopy. Aliment Pharmacol Ther. 1996 Dec;10(6):975-9.
• Ristikankare M, Hartikainen J, Heikkinen M, Julkunen R. Is routine sedation or topical pharyngeal anesthesia beneficial during upper endoscopy? Gastrointest Endosc. 2004 Nov;60(5):686-94.
• Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anaesthesiologist administration of propofol for GI endoscopy. Eur J Anaesthesiol. 2010 Dec;27(12):1016-30.

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