Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-02 @ 12:31 AM
Study NCT ID:
NCT06637956
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2024-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Intranasally Administered Nitroglycerin on Hemodynamic Response to Laryngoscopy and Intubation Among Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005996', 'term': 'Nitroglycerin'}], 'ancestors': [{'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-09', 'studyFirstSubmitDate': '2024-10-07', 'studyFirstSubmitQcDate': '2024-10-09', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean aterial pressure', 'timeFrame': '5 minutes post intubation', 'description': 'Mean arterial pressure was measured prior to and after intubation'}, {'measure': 'Heart rate', 'timeFrame': '5 minutes post intubation', 'description': 'Heart rate was measure prior to and after intubation'}, {'measure': 'Systolic blood pressure', 'timeFrame': '5 minutes post intubation', 'description': 'Systolic blood pressure was measure prior to and after itubation'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '5 minutes post intubation', 'description': 'Diastolic blood pressure was measure prior to and after intubation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intranasal', 'nitroglycerin', 'hemodynamic response', 'larayngoscopy', 'intubation', 'coronary artery bypass grafting'], 'conditions': ['Coronary Artery Bypass Grafting']}, 'descriptionModule': {'briefSummary': 'Numerous preventive medications have been used to lessen the cardiovascular response to laryngoscopy and intubation. Though some advantages have been noted, most of these treatments have not been found to be completely satisfying. However, nitroglycerin is the most widely utilized medicine due to its fast effect, short half-life, and absence of sedative qualities.', 'detailedDescription': 'The circulatory system under compromise is less resilient to the effects of general anaesthesia. Inducing anaesthesia is a crucial step for cardiac patients because their impaired circulatory systems are less tolerant to depression. During coronary artery bypass grafting surgery, the primary objective of general anesthesia is to reduce sympathetic response to uncomfortable stimuli, including laryngoscopy, intubation, skin incision, sternal splitting, and spreading. A rise in blood pressure is one of the hemodynamic reactions that is typically associated with tracheal intubation and laryngoscopy. The impact of intra nasally delivered nitroglycerin on blood pressure response to laryngoscopy and intubation in patients having non-cardiac surgery is currently contentious; however, this study focus on coronary artery bypass grafting surgery patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders\n* Patients undergoing coronary artery bypass grafting surgery.\n* Patients aged 35-60 years.\n* Ejection Fraction between 50-60%.\n* American Society of Anesthesiologists Classification 3-4.\n\nExclusion Criteria:\n\n* Known hypersensitivity to nitroglycerin.\n* Anticipated difficult airway.\n* Emergency surgery.'}, 'identificationModule': {'nctId': 'NCT06637956', 'briefTitle': 'The Effect of Intranasally Administered Nitroglycerin on Hemodynamic Response to Laryngoscopy and Intubation Among Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery', 'organization': {'class': 'OTHER', 'fullName': 'RESnTEC, Institute of Research'}, 'officialTitle': 'The Effect of Intranasally Administered Nitroglycerin on Hemodynamic Response to Laryngoscopy and Intubation Among Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery', 'orgStudyIdInfo': {'id': 'PIC_Lahore'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NTG', 'description': 'Received a mg nitroglycerin intranasally two minutes prior to laryngoscopy and intubation', 'interventionNames': ['Drug: Nitroglycerin (NTG)']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control group did not receive nitroglycerine prior to laryngoscopy and intubation'}], 'interventions': [{'name': 'Nitroglycerin (NTG)', 'type': 'DRUG', 'description': 'Received 1 mg of nitroglycerin intranasally two minutes prior to laryngoscopy and intubation', 'armGroupLabels': ['NTG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Department of Anesthesia, Rashid Latif Medical College', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Shehryar Ahmed, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of anesthesia Rashid Latif Medical college, Lahore, Pakistan'}, {'name': 'Syed Shakeel Ahmed, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesia, Shahida Islam Teaching Hospital, Lodhran, Pakistan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhammad Aamir Latif', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Consultant', 'investigatorFullName': 'Muhammad Aamir Latif', 'investigatorAffiliation': 'RESnTEC, Institute of Research'}}}}