Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT01081002
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2010-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'C000713218', 'term': 'gentian root extract'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 294}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-02', 'studyFirstSubmitDate': '2010-03-02', 'studyFirstSubmitQcDate': '2010-03-04', 'lastUpdatePostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number triggered gag reflex during the intubation of the endoscope', 'timeFrame': 'Start of the exam until the successful intubation of the esophagus with the endoscope'}, {'measure': 'Number of attempts of intubation with the endoscope through the upper esophageal sphincter', 'timeFrame': 'Start of the exam until the successful intubation of the esophagus with the endoscope'}, {'measure': 'Extent of salivation during intubation', 'timeFrame': 'Start of the exam until the successful intubation of the esophagus with the endoscope'}], 'secondaryOutcomes': [{'measure': 'Amount of propofol used to successfully intubate the esophagus', 'timeFrame': 'Start of the exam until the successful intubation of the esophagus with the endoscope'}, {'measure': 'Total amount of propofol used during the investigation', 'timeFrame': 'From the start until the end of the exam'}, {'measure': 'Overall assessment of the procedure by the endoscopist', 'timeFrame': 'Immediately after finishing the endoscopy'}, {'measure': 'Assumption of the endoscopist if lidocaine or placebo has been used', 'timeFrame': 'Immediately after finishing the endoscopy'}, {'measure': 'Overall assessment of the investigation by the patient', 'timeFrame': 'Immediately after recovery of consciousness of the patient'}, {'measure': 'Extent of amnesia in the patient', 'timeFrame': 'Immediately after recovery of consciousness of the patient'}, {'measure': 'Experienced problems (aspiration, bronchospasm, desaturation)', 'timeFrame': 'From the start until the end of the exam'}, {'measure': 'The impact of the individual endoscopists or registered nurses involved in the endoscopy', 'timeFrame': 'After finishing the entire study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Propofol', 'Conscious sedation', 'Topical pharyngeal anesthesia', 'Anesthetics, Local', 'Gastrointestinal Endoscopy'], 'conditions': ['Conscious Sedation']}, 'referencesModule': {'references': [{'pmid': '22000794', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'It is unclear whether a topical pharyngeal anesthesia adds any benefit to the upper gastrointestinal endoscopy under a propofol sedation. We hypothesize that a topical pharyngeal anesthesia does not ease the upper gastrointestinal endoscopy under propofol sedation. The aim of this study is therefore to quantify the impact of a topical pharyngeal anesthesia to the upper gastrointestinal endoscopy in patients sedated with propofol.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled diagnostic upper endoscopy\n* Wish to be sedated\n* ASA class I - III\n* Signed informed consent\n\nExclusion Criteria:\n\n* Emergency medical examinations\n* Therapeutic Endoscopy\n* ASA class IV\n* Pregnancy\n* Known allergy to propofol or lidocaine'}, 'identificationModule': {'nctId': 'NCT01081002', 'briefTitle': 'Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Study of Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia', 'orgStudyIdInfo': {'id': 'EKBB 101/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Anesthesia (=A) with lidocaine 10%', 'description': '3 min before sedation 4 puffs of terbutaline diluted lidocaine solution (Xylocaine ® 10% spray, Astra Zeneca, London, UK) will be sprayed on the pharynx', 'interventionNames': ['Drug: Lidocaine 10%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'A with diluted gentian root solution', 'description': '3 min before sedation 4 puffs of highly diluted gentian solution will be sprayed on the pharynx', 'interventionNames': ['Drug: Diluted gentian root solution']}], 'interventions': [{'name': 'Lidocaine 10%', 'type': 'DRUG', 'otherNames': ['Xylocaine 10% spray'], 'description': '3 min before the endoscopy under propofol sedation 4 puffs of lidocaine 10% will be sprayed on the pharynx as a pharyngeal anesthesia', 'armGroupLabels': ['Anesthesia (=A) with lidocaine 10%']}, {'name': 'Diluted gentian root solution', 'type': 'DRUG', 'otherNames': ['Gentian root extract, CAS no. 72968-42-4'], 'description': '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', 'armGroupLabels': ['A with diluted gentian root solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'University Hospital; Division of Gastroenterology and Hepatology', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '8125', 'city': 'Zollikerberg', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Hospital of Zollikerberg, Internal Medicine', 'geoPoint': {'lat': 47.3451, 'lon': 8.60088}}], 'overallOfficials': [{'name': 'Ludwig T Heuss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spital Zollikerberg'}, {'name': 'Lukas Degen, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Lukas Degen', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}