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

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

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 Overview

• Status: Completed
• Conditions: Esophagogastroduodenoscopy
• Intervention / Treatment: Drug: Lidocaine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Parla, Madrid, Spain, 28980
      • Hospital Universitario Infanta Cristina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine group; Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD)	Drug: Lidocaine; Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff).
Placebo Comparator: Placebo; Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.	Drug: Placebo; Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	8 months

Collaborators and Investigators

• Sponsor: Hospital Universitario Infanta Cristina
• Investigators: Principal Investigator: Felipe de la Morena, M.D.

Publications and helpful links

General Publications

• Jimenez-Puente G, Hidalgo-Isla M. [Use of topical pharyngeal anaesthesia in esophagogastroduodenoscopy in unsedated patients]. Enferm Clin. 2011 Jan-Feb;21(1):30-4. doi: 10.1016/j.enfcli.2010.07.008. 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. doi: 10.1055/s-0029-1214865. 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. doi: 10.1016/j.gie.2005.11.059.
• Lachter J, Jacobs R, Lavy A, Weisler A, Suissa A, Enat R, Eidelman S. Topical pharyngeal anesthesia for easing endoscopy: a double-blind, randomized, placebo-controlled study. Gastrointest Endosc. 1990 Jan-Feb;36(1):19-21. doi: 10.1016/s0016-5107(90)70915-7.
• 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. doi: 10.1046/j.1365-2036.1996.89261000.x.
• 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. doi: 10.1016/s0016-5107(04)02048-6.
• 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. doi: 10.1097/EJA.0b013e32834136bf.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: December 3, 2011
• First Submitted That Met QC Criteria: December 8, 2011
• First Posted (Estimate): December 12, 2011

Study Record Updates

• Last Update Posted (Estimate): March 8, 2013
• Last Update Submitted That Met QC Criteria: March 7, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Propofol; Lidocaine; Esophagogastroduodenoscopy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 2011-005704-15; ATF-EGD001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No