Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-21 @ 5:55 PM
Study NCT ID:
NCT06584461
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Lidocaine in Children with Upper Airway Infection Undergoing General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007826', 'term': 'Laryngismus'}, {'id': 'D001986', 'term': 'Bronchial Spasm'}, {'id': 'D003371', 'term': 'Cough'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D064706', 'term': 'Vocal Cord Dysfunction'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D001982', 'term': 'Bronchial 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': 'D008012', 'term': 'Lidocaine'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-04', 'studyFirstSubmitDate': '2024-09-02', 'studyFirstSubmitQcDate': '2024-09-02', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Perioperative Respiratory Complications', 'timeFrame': 'Within the first 2 hours post-operation.', 'description': 'Measure the occurrence of perioperative respiratory complications (e.g., laryngospasm, cough, desaturation, bronchospasm) from the induction of anesthesia until discharge from the recovery room.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Side Effects Related to IV Lidocaine', 'timeFrame': 'Within the first 24 hours post-operation.', 'description': 'Measure the occurrence of side effects such as nausea, vomiting, cardiac or neurological toxicity, and signs of anaphylaxis following the administration of IV lidocaine.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['upper respiratory tract infections', 'IV lidocaine', 'General anesthesia', 'children', 'laryngospasm', 'bronchospasm', 'cough', 'perioperative respiratory complications'], 'conditions': ['Upper Respiratory Tract Infections', 'Perioperative Respiratory Complications']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine whether intravenous (IV) lidocaine reduces the incidence of perioperative respiratory complications (PRCs) in children with upper respiratory tract infections undergoing general anesthesia. The study will also evaluate the safety of IV lidocaine in this population. The main questions it aims to answer are:\n\n1. Does IV lidocaine lower the incidence of perioperative respiratory complications (e.g., laryngospasm, cough, desaturation) compared to a placebo?\n2. What are the side effects associated with the administration of IV lidocaine in these children? Researchers will compare IV lidocaine to a placebo to assess its effectiveness in reducing PRCs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 1 to 14 years.\n* American Society of Anesthesiologists (ASA) Physical Status Classification I, II, or III.\n* Scheduled or urgent surgery or radiological exploration under general anesthesia.\n* Upper respiratory tract infection (URTI) symptoms present for less than 15 days.\n\nExclusion Criteria:\n\n* Refusal of participation by parents.\n* Children on long-term corticosteroid or bronchodilator therapy.\n* Contraindications to the use of lidocaine or other drugs used in the protocol.\n* Patients who did not adhere to the study protocol.'}, 'identificationModule': {'nctId': 'NCT06584461', 'briefTitle': 'Interest of Lidocaine in Children with Upper Airway Infection Undergoing General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Tunis University'}, 'officialTitle': 'Lidocaine in Children with Upper Airway Infection Undergoing General Anesthesia: Interventional Controlled Randomized Double Blind Study', 'orgStudyIdInfo': {'id': '092023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group L: IV Lidocaine Group', 'description': 'Participants in this group will receive a volume of weight\\*0.15 ml intravenous (IV) lidocaine at a dose of 1.5 mg/kg diluted to 10 mg/mL, administered at the induction of anesthesia..', 'interventionNames': ['Drug: Lidocaine (drug)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group P: Placebo Group', 'description': 'Participants in this group will receive an intravenous placebo (normal saline solution), equivalent in volume (weight\\*0.15 ml) to the lidocaine group, administered at the induction of anesthesia.', 'interventionNames': ['Drug: Saline (NaCl 0,9 %) (placebo)']}], 'interventions': [{'name': 'Lidocaine (drug)', 'type': 'DRUG', 'description': 'IV lidocaine, administered once during the induction of anesthesia.', 'armGroupLabels': ['Group L: IV Lidocaine Group']}, {'name': 'Saline (NaCl 0,9 %) (placebo)', 'type': 'DRUG', 'description': 'IV placebo (normal saline), administered once during the induction of anesthesia.', 'armGroupLabels': ['Group P: Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1029', 'city': 'Tunis', 'country': 'Tunisia', 'facility': "Bechir Hamza Children's Hospital", 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tunis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor of Anesthesiology and Intensive Care, head chief of the department of Anesthesia and Intensive Care', 'investigatorFullName': 'Mehdi Trifa', 'investigatorAffiliation': 'Tunis University'}}}}