Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-25 @ 1:54 AM
Study NCT ID:
NCT06777966
Status:
RECRUITING
Last Update Posted:
2025-01-22
First Post:
2025-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nebulized Versus Intravenous Tranexamic Acid on Surgical Field Quality in Patients Undergoing Endoscopic Sinus Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-19', 'studyFirstSubmitDate': '2025-01-11', 'studyFirstSubmitQcDate': '2025-01-11', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The mean Wormald intraoperative surgical field grading', 'timeFrame': '5 hours', 'description': 'The mean value of Wormald intraoperative surgical field grading throughout the intraoperative period, where 0 means no bleeding and 10 means severe bleeding with nasal cavity filling rapidly'}], 'secondaryOutcomes': [{'measure': 'Total blood loss', 'timeFrame': '5 hours', 'description': 'calculated by measuring the volume of the blood in the suction reservoir minus the normal saline used to wash the surgical field'}, {'measure': 'Bleeding rate', 'timeFrame': '5 hours', 'description': 'calculated as the total blood loss divided by the surgical time'}, {'measure': 'Operation time', 'timeFrame': '5 hours', 'description': 'Time starting from induction of anesthesia till completion of the surgical procedure'}, {'measure': 'Postoperative complications', 'timeFrame': '24 hours', 'description': 'nausea, vomiting, anaphylaxis, visual impairment, seizure, venous thromboembolism'}, {'measure': 'postoperative nasal bleeding', 'timeFrame': '48 hours', 'description': 'Incidence of postoperative nasal bleeding'}, {'measure': 'postoperative intervention', 'timeFrame': '48 hours', 'description': 'Incidence of the need for postoperative intervention to control nasal bleeding'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nebulization', 'Intravenous', 'Surgical Field', 'Endoscopic Sinus Surgeries']}, 'descriptionModule': {'briefSummary': 'Intraoperative bleeding is one of the vital problems for anesthesiologists and surgeons, during endoscopic nasal surgery; where the surgical field is very limited and surrounded by vital structures. The tinniest amount of blood in such surgical field can obscure the anatomy and clog the tip of the endoscope, requiring repeated irrigations and suctioning; both of which have traumatic effects on the friable nasal mucosa. Anesthetic techniques to minimize bleeding during endoscopic nasal surgery are of primary importance for a safe and effective procedure, reducing operative time and shortening post-operative recovery.\n\nGood surgical conditions could be achieved with systemic, topical, or regional anesthetic techniques. The use of topical and regional techniques has been gaining popularity in recent years as an alternative to the administration of heavy premedication, high narcotic doses, intravenous lignocaine, clonidine, calcium channel blockers, sodium nitroprusside, beta-adrenergic blockers, and magnesium sulfate, which may produce a lack of alertness, respiratory depression, hypoxia, nausea and vomiting, and delayed recovery.\n\nRecent studies have shown that the use of tranexamic acid could be a safe and effective management option for hemostasis in a wide range of specialties. Tranexamic acid (TXA) is a synthetic lysine derivative that blocks the lysine binding site on plasminogen, thus inactivating its conversion to plasmin and hence attenuating its fibrinolysis effects. When given as a one-time operative systemic dose, it can reduce intraoperative surgical blood loss. More recently, it has been used in its nebulized or topical form to treat bleeding in anatomically sequestered areas. Its use has been described for epistaxis, cancer-related hemoptysis, and post-tonsillectomy bleeding. Though systemic doses of tranexamic acid have proven their efficiency in reducing intraoperative bleeding, other forms of administration have not been widely researched. The use of nebulized form is expected to provide a targeted route and localized effect with reduced systemic side effects. Adverse effects of systemic administration of tranexamic acid include seizures, nausea, vomiting, diarrhea, pulmonary embolism, deep vein thrombosis, anaphylaxis, and other visual disturbance.\n\nThe purpose of this study was to assess the effect of pre-emptive nebulized tranexamic acid versus intravenous tranexamic acid on endoscopic visualization and bleeding rate during endoscopic sinus surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18 and 60 years.\n* American Society of Anesthesiologists (ASA) class I and II patients.\n* Endoscopic sinus surgeries under general anesthesia.\n\nExclusion Criteria:\n\n* Patient's refusal.\n* American Society of Anesthesiologists (ASA) class III or IV patients.\n* Underlying uncontrolled hypertension.\n* Known history bleeding disorder.\n* Patients on anticoagulant therapy.\n* Allergy to any of the drugs utilized in this study.\n* History of nonsteroidal anti-inflammatory drugs within 48 hours of scheduled surgery.\n* Inadvertent intra-operative vascular injury."}, 'identificationModule': {'nctId': 'NCT06777966', 'briefTitle': 'Nebulized Versus Intravenous Tranexamic Acid on Surgical Field Quality in Patients Undergoing Endoscopic Sinus Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Preoperative Nebulized Versus Intravenous Tranexamic Acid on Surgical Field Quality in Patients Undergoing Endoscopic Sinus Surgeries: a Randomized Controlled Comparative Study', 'orgStudyIdInfo': {'id': 'MD-206-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nebulized group', 'description': 'patients will receive nebulized tranexamic acid', 'interventionNames': ['Drug: nebulized tranexamic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous group', 'description': 'patients will receive intravenous tranexamic acid', 'interventionNames': ['Drug: intravenous tranexamic acid']}], 'interventions': [{'name': 'nebulized tranexamic acid', 'type': 'DRUG', 'description': 'patients will receive a preoperative nebulizer session of 500 mg of tranexamic acid. To ensure the blinding of the participating anesthetist and patient, patients in this group will receive an intravenous drip of 100 ml of 0.9% normal saline.', 'armGroupLabels': ['Nebulized group']}, {'name': 'intravenous tranexamic acid', 'type': 'DRUG', 'description': 'patients will receive a preoperative intravenous drip of TXA at a dose of 15 mg/kg in 100 ml of normal saline. To ensure blinding this group patients will receive 5 ml of 0.9% normal saline nebulizer session.', 'armGroupLabels': ['Intravenous group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Kareem MA Nawwar, M.D.', 'role': 'CONTACT', 'email': 'drknawwar@cu.edu.eg', 'phone': '+201003878369'}], 'facility': 'Faculty of Medicine, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Kareem MA Nawwar, M.D.', 'role': 'CONTACT', 'email': 'drknawwar@cu.edu.eg', 'phone': '+201003878369'}], 'overallOfficials': [{'name': 'Nevan M Abbas Elmekawy, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}, {'name': 'Tamer M Khair, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Kareem MA Nawwar, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Nadia E M Gaballah, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Kareem Mohammed Assem Nawwar', 'investigatorAffiliation': 'Cairo University'}}}}