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

NCT05841251 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-05-03

No results posted yet for this study

Summary

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".

Conditions

  • Intraoperative Bleeding
  • Coblation Turbinoplasty

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2023-09-01
Completion
2023-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05841251 on ClinicalTrials.gov