Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Phenylephrine Versus Tranexamic Acid to Control Bleeding in Patients Undergoing Inferior Turbinoplasty by Coblation

ID
Name
27111344
Description
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".
Trial arms
Trial start
2023-05-01
Estimated PCD
2023-09-01
Trial end
2023-12-01
Status
Not yet recruiting
Treatment
Topical Phenylephrine Solution
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.
Arms:
phenylephrine
intravenous tranexamic acid
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.
Arms:
tranexamic acid
Size
80
Primary endpoint
surgical field scale
intraoperativel
Eligibility criteria
Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status I and II * Scheduled patients for Coblation Turbinoplasty surgery with inferior turbinate hypertrophy Exclusion Criteria: * Known allergy to study drugs. * History of coagulopathy or bleeding disorders. * Patients with hypertension or ischemic heart disease. * patients on anticoagulants, antiplatelets or NSAIDs * history of deep vein thrombosis, stroke or peripheral vascular disease.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-05-03

1 organization

2 products

2 indications

Organization
Assiut University
Product
Topical Phenylephrine
Indication
Intraoperative Bleeding
Indication
Coblation Turbinoplasty
Product
Tranexamic acid