Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-28 @ 12:04 PM
Study NCT ID:
NCT05298761
Status:
UNKNOWN
Last Update Posted:
2023-11-21
First Post:
2022-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of I/v Nalbuphine v/s Iv Lignocain in Attanuation of Pressor Responseduring Laryngeoscopy and Intubation in Middle Age Patient Planned for Thyroid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D009266', 'term': 'Nalbuphine'}], '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': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2022-02-22', 'studyFirstSubmitQcDate': '2022-03-17', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduce stress response during intubation and hemodynamic stabilty', 'timeFrame': '10 minutes', 'description': 'Assesment of Hemodynamic stability by observing vital signs'}, {'measure': 'Achieve hemodynamic stabilty and smooth intubation', 'timeFrame': '10 minutes', 'description': 'Assesment of hemodynamic stability by clinical examination of vital signs'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemodynamic Stability']}, 'descriptionModule': {'briefSummary': 'Comparison of I/V nalbuphine versus I/V xylocain in attanuation of pressor response during intubation and laryngeoscopy in patients undergoing for thyroid surgery,selection of better supressor agent minimises the drug repated side effects like hypertention tachycardia but also helps in heamodynamically stability at induction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* middle age(18\\_40)\n* Asa 1 and 2\n* Non hypertensive\n* Thyroid patients\n* patient who gives consent\n\nExclusion Criteria:\n\n* hypertensive\n* Asa 3 and 4\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT05298761', 'briefTitle': 'Efficacy of I/v Nalbuphine v/s Iv Lignocain in Attanuation of Pressor Responseduring Laryngeoscopy and Intubation in Middle Age Patient Planned for Thyroid Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheikh Zayed Medical College'}, 'officialTitle': 'Efficacy of IV Lignocaine Versus IV Nalbuphine for Attenuation of Pressor Response Diring Laryngoscopy and Intubation in Patients Planned for Thyroid Surgery', 'orgStudyIdInfo': {'id': 'ASarwar'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lignocain', 'description': 'I/V lignocain 1.5mg per kg given to participants in state dose', 'interventionNames': ['Drug: Lignocaine']}, {'type': 'EXPERIMENTAL', 'label': 'nalbuphine', 'description': 'I/v nalbuphine 0.1mg per kg given to participants in stat dose', 'interventionNames': ['Drug: Lignocaine']}], 'interventions': [{'name': 'Lignocaine', 'type': 'DRUG', 'otherNames': ['Nalbuphine'], 'description': 'Inj lignocain and inj nalbuphine given to two groups of participants and effects of both drugs', 'armGroupLabels': ['Lignocain', 'nalbuphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '092', 'city': 'Rahim Yar Khan', 'state': 'Punjab Province', 'country': 'Pakistan', 'contacts': [{'name': 'Dr.amna Sarwar, Fcps', 'role': 'CONTACT', 'email': 'Dr.amnasabir@gmail.com', 'phone': '03218337129'}], 'facility': 'Dr.amna', 'geoPoint': {'lat': 28.41987, 'lon': 70.30345}}], 'centralContacts': [{'name': 'Dr.amna Sarwar, Fcps', 'role': 'CONTACT', 'email': 'Dr.amnasabir@gmail.com', 'phone': '03218337129'}], 'overallOfficials': [{'name': 'Dr.amna Sarwar, Fcps', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheikh zaied medical hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheikh Zayed Medical College', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Amna Sarwar', 'investigatorAffiliation': 'Sheikh Zayed Medical College'}}}}