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

Assiut University

Status: Not yet enrolling

Conditions: Coblation Turbinoplasty; Intraoperative Bleeding

Treatments: Drug: Topical Phenylephrine Solution; Drug: intravenous tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05841251

27111344

Details and patient eligibility

About

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".

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

phenylephrine

Active Comparator group

Description:

phenylephrine-soaked pack will be applied after induction of surgery and intubation.

Treatment:

Drug: Topical Phenylephrine Solution

tranexamic acid

Active Comparator group

Description:

Single intravenous dose of tranexamic acid 15 mg/kg will be given in 100 mL normal saline over 10 minutes.

Treatment:

Drug: intravenous tranexamic acid