Usefulness of Lidocaine as Topical Pharyngeal Anaesthesia in Esophagogastroduodenoscopy Under Sedation With Propofol
NCT ID: NCT01489891
Last Updated: 2013-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2011-12-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Lidocaine group
Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD)
Lidocaine
Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff).
Placebo
Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.
Placebo
Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking).
Interventions
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Lidocaine
Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff).
Placebo
Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Hospital Universitario Infanta Cristina
OTHER
Responsible Party
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Felipe de la Morena Lopez MD
Gastroenterologist. Head of endoscopy
Principal Investigators
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Felipe de la Morena, M.D.
Role: PRINCIPAL_INVESTIGATOR
Locations
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Hospital Universitario Infanta Cristina
Parla, Madrid, Spain
Countries
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References
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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.
Other Identifiers
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ATF-EGD001
Identifier Type: -
Identifier Source: secondary_id
2011-005704-15
Identifier Type: -
Identifier Source: org_study_id
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