Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 4:25 PM
Study NCT ID:
NCT04000633
Status:
UNKNOWN
Last Update Posted:
2019-06-27
First Post:
2019-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nebulized Lidocaine to Prevent Cough at Emergence From Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}, {'id': 'D010612', 'term': 'Pharyngitis'}], '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'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'The investigator will provide to the anesthesiologist 1 seringue containing either lidocaine or normal saline to be nebulized before induction of general anesthesia'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 groups comparaison between nebulized lidocaine versus placebo for prevention of cough at emergence from general anesthesia and post extubation sore throat'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-26', 'studyFirstSubmitDate': '2019-06-26', 'studyFirstSubmitQcDate': '2019-06-26', 'lastUpdatePostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of cough at emergence from general anesthesia', 'timeFrame': '30 minutes after the end of surgery', 'description': 'evaluation of incidence of cough at emergence from general anesthesia'}], 'secondaryOutcomes': [{'measure': 'incidence of sore throat', 'timeFrame': '24 hours after tracheal extubation', 'description': 'evaluation of incidence of sore throat'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cough, General Anesthesia, Extubation, Lidocaine, Sore Throat']}, 'descriptionModule': {'briefSummary': 'our study aimed to evaluate the effect of nebulized lidocaine to decrease the incidence of cough and sore throat after extubation after surgeries requiring endotracheal intubation.', 'detailedDescription': 'our study aimed to evaluate the effect of nebulized lidocaine to decrease the incidence of cough and sore throat after extubation after surgeries requiring endotracheal intubation.\n\nThis randomized controlled study will compare the effect of Lidocaine and placebo nebulization in the immediate pre operative period in order to evaluate the effectiveness in reducing post extubation cough and sore throat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age\\>18 years\n* ASA status I or II\n\nExclusion Criteria:\n\n* Unexpected difficult laryngoscopy\n* Surgery\\>3 hours'}, 'identificationModule': {'nctId': 'NCT04000633', 'briefTitle': 'Nebulized Lidocaine to Prevent Cough at Emergence From Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Mongi Slim Hospital'}, 'officialTitle': 'Nebulized Lidocaine Versus Placebo to Prevent Cough at Emergence From Anesthesia: a Double Blind Prospective Randomised Trial', 'orgStudyIdInfo': {'id': 'lidocaïne cough prevention'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'lidocaine group', 'description': 'the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia', 'interventionNames': ['Drug: Lidocaine 2%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'the patients of this group will recieve nebulization of 5 ml of normal saline prior to induction of general anesthesia', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Lidocaine 2%', 'type': 'DRUG', 'description': 'the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia', 'armGroupLabels': ['lidocaine group']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'Normal saline', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2046', 'city': 'La Marsa', 'state': 'Tunis Governorate', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'Mhamed Sami Mebazaa, professor', 'role': 'CONTACT', 'email': 'msmebazaa@gmail.com', 'phone': '0021622252589'}, {'name': 'Asma Ben Souissi, Ass Prof', 'role': 'CONTACT', 'email': 'bsouissiasma@gmail.com', 'phone': '0021698336883'}], 'facility': 'Mongi Slim Hospital', 'geoPoint': {'lat': 36.87818, 'lon': 10.32466}}], 'centralContacts': [{'name': 'Mhamed Sami Mebazaa, professor', 'role': 'CONTACT', 'email': 'msmebazaa@gmail.com', 'phone': '0021622252589'}, {'name': 'Hajer Arfaoui', 'role': 'CONTACT', 'email': 'hejer_arfaoui@hotmail.fr', 'phone': '0021699336661'}], 'overallOfficials': [{'name': 'Mhamed Sami Mebazaa, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mongi Slim Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mongi Slim Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Mhamed Sami Mebazaa', 'investigatorAffiliation': 'Mongi Slim Hospital'}}}}