Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-30 @ 10:34 AM
Study NCT ID:
NCT05841251
Status:
UNKNOWN
Last Update Posted:
2023-05-03
First Post:
2023-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phenylephrine Versus Tranexamic Acid to Control Bleeding in Patients Undergoing Inferior Turbinoplasty by Coblation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016063', 'term': 'Blood Loss, Surgical'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-22', 'studyFirstSubmitDate': '2023-04-11', 'studyFirstSubmitQcDate': '2023-04-22', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'surgical field scale', 'timeFrame': 'intraoperativel', 'description': 'the intraoperative surgical site bleeding using the surgical field scale as follows: 0 = No bleeding\n\n1. = Minimal bleeding: Not a surgical nuisance and no suction required\n2. = Mild bleeding: Occasional suction required, but does not affect dissection\n3. = Moderate bleeding: Slightly compromises surgical field, frequent suction required\n4. = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction\n5. = Massive bleeding: Prevent dissection.'}], 'secondaryOutcomes': [{'measure': 'Volume of Blood loss', 'timeFrame': 'intraoperative'}, {'measure': 'Duration of surgery', 'timeFrame': 'the duration from induction of anesthesia till extubation'}, {'measure': 'Avoidance of postoperative nasal packing', 'timeFrame': 'immediately after the surgey', 'description': 'if the patient can be spared from postoperatiove nasal pack inserted for controllling bleeding'}, {'measure': 'Intra-operative and Postoperative complications', 'timeFrame': 'intraoperative and 24 hours postoperative', 'description': 'Complications such as nausea, vomiting, hypotnsion, hypertension, hemorraghic or thrombotic manifestations for 24 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraoperative Bleeding', 'Coblation Turbinoplasty']}, 'descriptionModule': {'briefSummary': 'Coblation is a unique method of delivering radio frequency energy to the soft tissue for applications in otolaryngology. It induces reduction of the inferior turbinate by vaporizing and destroying the soft erectile tissue. The volume reduction and tissue fibrosis are immediate and sustainable. Bleeding from the vascular capillary beds of the sinonasal mucosa compromises the surgical field and increases operative time and risk of complications. In this study we try to assist hemostasis with a multifaceted approach, including use of topical vasoconstrictors "phenylephrine" and systemic antifibrinolytic agent "tranexamic acid".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I and II\n* Scheduled patients for Coblation Turbinoplasty surgery with inferior turbinate hypertrophy\n\nExclusion Criteria:\n\n* Known allergy to study drugs.\n* History of coagulopathy or bleeding disorders.\n* Patients with hypertension or ischemic heart disease.\n* patients on anticoagulants, antiplatelets or NSAIDs\n* history of deep vein thrombosis, stroke or peripheral vascular disease.'}, 'identificationModule': {'nctId': 'NCT05841251', 'briefTitle': 'Phenylephrine Versus Tranexamic Acid to Control Bleeding in Patients Undergoing Inferior Turbinoplasty by Coblation', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Phenylephrine Versus Tranexamic Acid to Control Bleeding in Patients Undergoing Inferior Turbinoplasty by Coblation', 'orgStudyIdInfo': {'id': '27111344'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'phenylephrine', 'description': 'phenylephrine-soaked pack will be applied after induction of surgery and intubation.', 'interventionNames': ['Drug: Topical Phenylephrine Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tranexamic acid', 'description': 'Single intravenous dose of tranexamic acid 15 mg/kg will be given in 100 mL normal saline over 10 minutes.', 'interventionNames': ['Drug: intravenous tranexamic acid']}], 'interventions': [{'name': 'Topical Phenylephrine Solution', 'type': 'DRUG', 'description': 'phenylephrine-soaked pack using the whole 5 ml of the solution provided with.5% phenylephrine will be applied after induction of surgery and intubation, 15 minutes before surgery. 100 ml of normal saline will be given.', 'armGroupLabels': ['phenylephrine']}, {'name': 'intravenous tranexamic acid', 'type': 'DRUG', 'description': 'patients will receive intravenous Single dose of tranexamic acid 15 mg/kg in 100 mL normal saline over 10 minutes. Saline-soaked pack will be applied.', 'armGroupLabels': ['tranexamic acid']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed A Mohammed, M.D.', 'role': 'CONTACT', 'email': 'ahmedfotoh86@aun.edu.eg', 'phone': '01060757593'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of Anesthesia and icu', 'investigatorFullName': 'Ahmed Aboulfotouh Mohammed', 'investigatorAffiliation': 'Assiut University'}}}}