Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-15 @ 2:37 AM
Study NCT ID:
NCT00528502
Status:
WITHDRAWN
Last Update Posted:
2012-12-07
First Post:
2007-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lidocaine Supplement for Minimal Invasive Parathyroid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010279', 'term': 'Parathyroid Diseases'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Terminated due to no patient enrollment.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-05', 'studyFirstSubmitDate': '2007-09-11', 'studyFirstSubmitQcDate': '2007-09-11', 'lastUpdatePostDateStruct': {'date': '2012-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of Airway Interruption', 'timeFrame': 'Assessment made by surgeon during minimally invasive parathyroidectomy surgery'}, {'measure': 'Quality of Operative Field', 'timeFrame': 'Assessment made by surgeon during minimally invasive parathyroidectomy surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Parathyroid Disease', 'Minimal Invasive Parathyroid Surgery', 'MIPS', 'Laryngeal Reflexes', 'Lidocaine', 'Saline'], 'conditions': ['Parathyroid Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'UT MD Anderson Cancer Center official web site'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n1\\. To determine if the application of lidocaine to the airway will obtund or abolish the laryngeal reflexes. This in turn will lead to a quiescent controlled surgical field.', 'detailedDescription': 'Lidocaine is a local anesthetic that causes numbness to the throat when misted into the air. This numbness in the throat should stop the urge to clear the throat in the middle of the operation. Therefore, this should stop the interruptions during the surgery.\n\nIf you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 groups. Participants in Group 1 will receive the saline mist. This will moisturize and soothe the throat. Participants in Group 2 will receive the lidocaine mist. Lidocaine or saline is misted into the air that you breathe during the surgery. You and your surgeon will not be told which group you were assigned to. At the end of the surgery, your surgeon will answer some questions to help determine if the use of lidocaine or saline is beneficial.\n\nYou will be considered off-study once you are sent to the recovery room after surgery.\n\nThis is an investigational study. Lidocaine is FDA-approved and commercially available for local anesthesia. If you are in the lidocaine or the saline group. Up to 105 patients will take part in this study. All will be enrolled at M. D. Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All outpatients scheduled for MIPS at the ACB by Dr N Perrier, Dr D Evans and Dr JE Lee.\n\nExclusion Criteria:\n\n* Patients who are excluded will be any who require elective endotracheal intubation as a preoperative decision by the anesthesia team. These patients will be those with sleep apnea, BMI\\>35, uncontrolled gastro esophageal reflux.\n* Patients who have a history of allergy/hypersensitivity to lidocaine.'}, 'identificationModule': {'nctId': 'NCT00528502', 'briefTitle': 'Lidocaine Supplement for Minimal Invasive Parathyroid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Prevention of Laryngeal Reflexes in Minimal Invasive Parathyroid Surgery by the Use of Topical Lidocaine', 'orgStudyIdInfo': {'id': '2006-0147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saline', 'description': 'Saline misted into the air breathe during the surgery.', 'interventionNames': ['Drug: Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Lidocaine', 'description': 'Lidocaine misted into the air during the surgery.', 'interventionNames': ['Drug: Lidocaine']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Lidocaine is misted into the air that you breathe during the surgery.', 'armGroupLabels': ['Lidocaine']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'Saline is misted into the air that you breathe during the surgery.', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Spencer Kee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}