Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-26 @ 9:44 AM
Study NCT ID:
NCT01774292
Status:
COMPLETED
Last Update Posted:
2015-10-30
First Post:
2013-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-29', 'studyFirstSubmitDate': '2013-01-04', 'studyFirstSubmitQcDate': '2013-01-19', 'lastUpdatePostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coughing', 'timeFrame': '24 hours after the end ofsurgery'}], 'secondaryOutcomes': [{'measure': 'Throat pain', 'timeFrame': '24 hours after the end of surgery'}, {'measure': 'Nausea and Vomiting', 'timeFrame': '24 hours after end of surgery'}, {'measure': 'Hoarseness of the voice', 'timeFrame': '24 hours after end of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Impact of alkalized lidocaine on coughing at extubation'], 'conditions': ['Coughing', 'Extubation', 'Lidocaine', 'Endotracheal Cuff']}, 'referencesModule': {'references': [{'pmid': '14970135', 'type': 'BACKGROUND', 'citation': 'Estebe JP, Delahaye S, Le Corre P, Dollo G, Le Naoures A, Chevanne F, Ecoffey C. Alkalinization of intra-cuff lidocaine and use of gel lubrication protect against tracheal tube-induced emergence phenomena. Br J Anaesth. 2004 Mar;92(3):361-6. doi: 10.1093/bja/aeh078.'}, {'pmid': '16244028', 'type': 'BACKGROUND', 'citation': 'Estebe JP, Gentili M, Le Corre P, Dollo G, Chevanne F, Ecoffey C. Alkalinization of intracuff lidocaine: efficacy and safety. Anesth Analg. 2005 Nov;101(5):1536-1541. doi: 10.1213/01.ANE.0000180995.24211.89.'}, {'pmid': '11772834', 'type': 'BACKGROUND', 'citation': 'Estebe JP, Dollo G, Le Corre P, Le Naoures A, Chevanne F, Le Verge R, Ecoffey C. Alkalinization of intracuff lidocaine improves endotracheal tube-induced emergence phenomena. Anesth Analg. 2002 Jan;94(1):227-30, table of contents. doi: 10.1097/00000539-200201000-00044.'}, {'pmid': '11384855', 'type': 'BACKGROUND', 'citation': 'Dollo G, Estebe JP, Le Corre P, Chevanne F, Ecoffey C, Le Verge R. Endotracheal tube cuffs filled with lidocaine as a drug delivery system: in vitro and in vivo investigations. Eur J Pharm Sci. 2001 Jun;13(3):319-23. doi: 10.1016/s0928-0987(01)00119-1.'}, {'pmid': '22569622', 'type': 'BACKGROUND', 'citation': 'Navarro LH, Lima RM, Aguiar AS, Braz JR, Carness JM, Modolo NS. The effect of intracuff alkalinized 2% lidocaine on emergence coughing, sore throat, and hoarseness in smokers. Rev Assoc Med Bras (1992). 2012 Mar-Apr;58(2):248-53.'}, {'pmid': '27075030', 'type': 'DERIVED', 'citation': "Souissi H, Frechette Y, Murza A, Masse MH, Marsault E, Sarret P, D'Aragon F, Parent AJ, Sansoucy Y. Intracuff 160 mg alkalinized lidocaine reduces cough upon emergence from N2O-free general anesthesia: a randomized controlled trial. Can J Anaesth. 2016 Jul;63(7):862-70. doi: 10.1007/s12630-016-0652-8. Epub 2016 Apr 13."}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determined whether the administration of alkalized 4% lidocaine (160 mg) in the endotracheal tube cuff is effective in diminishing the incidence of coughing at extubation in surgeries lasting more than 2 hours without the use of nitrous oxide as an anesthetic agent.', 'detailedDescription': 'The diffusion of nitrous oxide inside the endotracheal cuff leads to increase pressure, pain and coughing. Studies have shown benefit of alkalized lidocaine and other mediums within the cuff with nitrous oxide. No study has yet evaluated the benefit of alkalized lidocaine in long surgeries without the use of nitrous oxide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- ASA 1,2 or 3 patients requiring general anesthesia for an elective urological or gynecological surgery predicted to last more than 2 hours\n\nExclusion Criteria:\n\n* Patient refusal\n* Lidocaine allergy\n* Any allergies to drugs or anesthetics used during the study\n* Under 18 years of age\n* Pregnant\n* Previous airway surgery\n* Cormack 3 or 4 or anticipated difficult airway\n* Upper respiratory tract infection in the last month\n* Active respiratory disease\n* Chronic cough or throat pain\n* Gastro-esophageal reflux disease or at risk for aspiration'}, 'identificationModule': {'nctId': 'NCT01774292', 'briefTitle': 'Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Evaluation of the Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation in Surgeries Without Nitrous Oxide Lasting More Than 2 Hours', 'orgStudyIdInfo': {'id': '12182'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Alkalized lidocaine', 'description': '160 mg of 4% lidocaine (4 ml) in the endotracheal cuff and add bicarbonate 8,4% until appropriate seal.', 'interventionNames': ['Procedure: Endotracheal intubation with injection of liquid in the cuff']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sterile saline', 'description': '4 mL of sterile saline in the endotracheal cuff and add bicarbonate 8,4% until appropriate seal.', 'interventionNames': ['Procedure: Endotracheal intubation with injection of liquid in the cuff']}], 'interventions': [{'name': 'Endotracheal intubation with injection of liquid in the cuff', 'type': 'PROCEDURE', 'armGroupLabels': ['Alkalized lidocaine', 'Sterile saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Yanick Sansoucy, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Yanick Sansoucy', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}