Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia
NCT ID: NCT01081002
Last Updated: 2014-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
294 participants
INTERVENTIONAL
2009-08-31
2010-05-31
Brief Summary
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Patients will be randomized to receive a topical pharyngeal spray containing either an anesthetic drug (lidocaine 10%) or a placebo. Thereafter the upper endoscopy will be conducted in its standard manner.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Anesthesia (=A) with lidocaine 10%
3 min before sedation 4 puffs of terbutaline diluted lidocaine solution (Xylocaine ® 10% spray, Astra Zeneca, London, UK) will be sprayed on the pharynx
Lidocaine 10%
3 min before the endoscopy under propofol sedation 4 puffs of lidocaine 10% will be sprayed on the pharynx as a pharyngeal anesthesia
A with diluted gentian root solution
3 min before sedation 4 puffs of highly diluted gentian solution will be sprayed on the pharynx
Diluted gentian root solution
As a basis, an infusion of water (45%), ethanol (35%) and gentian root cut will be used. The gentian root infusion is approved as a natural flavor in the food industry.3 min before the endoscopy under propofol sedation 4 puffs of this gentian root infusion will be sprayed on the pharynx as a pharyngeal anesthesia
Interventions
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Lidocaine 10%
3 min before the endoscopy under propofol sedation 4 puffs of lidocaine 10% will be sprayed on the pharynx as a pharyngeal anesthesia
Diluted gentian root solution
As a basis, an infusion of water (45%), ethanol (35%) and gentian root cut will be used. The gentian root infusion is approved as a natural flavor in the food industry.3 min before the endoscopy under propofol sedation 4 puffs of this gentian root infusion will be sprayed on the pharynx as a pharyngeal anesthesia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Wish to be sedated
* ASA class I - III
* Signed informed consent
Exclusion Criteria
* Therapeutic Endoscopy
* ASA class IV
* Pregnancy
* Known allergy to propofol or lidocaine
18 Years
85 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Lukas Degen
Prof.
Principal Investigators
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Ludwig T Heuss, MD
Role: PRINCIPAL_INVESTIGATOR
Spital Zollikerberg
Lukas Degen, Prof
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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University Hospital; Division of Gastroenterology and Hepatology
Basel, Canton of Basel-City, Switzerland
Hospital of Zollikerberg, Internal Medicine
Zollikerberg, Canton of Zurich, Switzerland
Countries
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References
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Heuss LT, Hanhart A, Dell-Kuster S, Zdrnja K, Ortmann M, Beglinger C, Bucher HC, Degen L. Propofol sedation alone or in combination with pharyngeal lidocaine anesthesia for routine upper GI endoscopy: a randomized, double-blind, placebo-controlled, non-inferiority trial. Gastrointest Endosc. 2011 Dec;74(6):1207-14. doi: 10.1016/j.gie.2011.07.072. Epub 2011 Oct 13.
Other Identifiers
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EKBB 101/09
Identifier Type: -
Identifier Source: org_study_id