Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-08 @ 9:10 PM
Study NCT ID:
NCT06040034
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2023-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bolus vs. Continuous IV Lidocaine Against Post-Extubation Cough in Post-Thyroidectomy Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparison'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2023-09-10', 'studyFirstSubmitQcDate': '2023-09-10', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-Extubation Cough Grade', 'timeFrame': '24 hours post operative', 'description': 'Cough graded according to the following criteria:\n\nGrade 0: no cough; Grade 1: mild, only 1 cough; Grade 2: moderate, \\>1 cough lasting \\<5 seconds; Grade 3: coughing heavily and continuously for \\>5 seconds)'}], 'secondaryOutcomes': [{'measure': 'Number of participant experiencing tachycardia', 'timeFrame': '24 hours perioperative', 'description': 'Tachycardia is defined as heart rate \\>100 beats per minute'}, {'measure': 'Number of participant experiencing bradycardia', 'timeFrame': '24 hours perioperative', 'description': 'Bradycardia is defined as heart rate \\<60 beats per minute'}, {'measure': 'Number of participant experiencing hypertension', 'timeFrame': '24 hours perioperative', 'description': 'Increase of blood pressure \\>20% from initial blood pressure'}, {'measure': 'Number of participant experiencing hypotension', 'timeFrame': '24 hours perioperative', 'description': 'Decrease of blood pressure \\<20% from initial blood pressure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cough']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled trial is to compare the effect of lidocaine bolus intravenous administration to lidocaine continuous intravenous administration in post thyroidectomy patients to observe the effect against post-extubation cough. The main questions it aims to answer are:\n\n* Cough incidence on both groups\n* Which method is preferable to reduce post-extubation cough incidence'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ASA class 1 and 2\n* Thyroidectomy patients in Hasan Sadikin Bandung Hospital\n\nExclusion Criteria:\n\n* Subjects' refusal\n* Had history of drug allergy, specifically lidaocaine\n* Had history of asthma or other lung diseases\n* Active smoker\n* History of arrhythmia\n* Bradycardia subjects (\\<60 beats per minute)\n* Pregnant people\n* Perioperative upper respiratory tract infusion\n* Routinely consume ACE inhibitor / bronchodilators / steroid\n* Renal dysfunction\n* Liver dysfunction"}, 'identificationModule': {'nctId': 'NCT06040034', 'briefTitle': 'Bolus vs. Continuous IV Lidocaine Against Post-Extubation Cough in Post-Thyroidectomy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Padjadjaran'}, 'officialTitle': 'Comparison of Bolus Intravenous Lidocaine Administration With Continuous Intravenous Lidocaine Against Post-Extubation Cough Incidence in Post-Thyroidectomy Patients', 'orgStudyIdInfo': {'id': 'AN-202309.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Lidocaine Intravenous Infusion', 'description': 'Patients were given a loading dose of 1.5 mg/kgBW intravenous lidocaine for 10 minutes before induction of anesthesia using a syringe pump, followed by continuous intravenous administration of 1.5 mg/kgBW/hour lidocaine until 30 minutes before the end of the surgery (when the skin is being sutured by the surgeon) using a syringe pump. Continuous administration of lidocaine was prepared by the research team as 10 cc of 20 mg/cc lidocaine in a 10 cc syringe and 10 cc of 0.9% NaCl in a 10 cc syringe.', 'interventionNames': ['Drug: Lidocaine IV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bolus Lidocaine Intravenous', 'description': 'Patients were given a loading dose of 1.5 mg/kgBW intravenous lidocaine for 10 minutes before induction of anesthesia using a syringe pump, followed by intravenous infusion of saline with the same volume until 30 minutes before the end of the surgery (when the skin is being sutured by the surgeon) using syringe pump.', 'interventionNames': ['Drug: Lidocaine IV']}], 'interventions': [{'name': 'Lidocaine IV', 'type': 'DRUG', 'description': 'Lidocaine given as bolus or continuous infusion.', 'armGroupLabels': ['Bolus Lidocaine Intravenous', 'Continuous Lidocaine Intravenous Infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40161', 'city': 'Bandung', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'Hasan Sadikin General Hospital', 'geoPoint': {'lat': -6.92222, 'lon': 107.60694}}], 'overallOfficials': [{'name': 'Iwan Fuadi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine Universitas Padjadjaran Bandung'}, {'name': 'Ardi Zulfariansyah, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine Universitas Padjadjaran Bandung'}, {'name': 'Ignatia K Hallis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine Universitas Padjadjaran Bandung'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Padjadjaran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}