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

April 22, 2023 updated by: Ahmed Aboulfotouh Mohammed, Assiut University
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".

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: phenylephrine
phenylephrine-soaked pack will be applied after induction of surgery and intubation.
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.
Active Comparator: tranexamic acid
Single intravenous dose of tranexamic acid 15 mg/kg will be given in 100 mL normal saline over 10 minutes.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgical field scale
Time Frame: intraoperativel

the intraoperative surgical site bleeding using the surgical field scale as follows: 0 = No bleeding

  1. = Minimal bleeding: Not a surgical nuisance and no suction required
  2. = Mild bleeding: Occasional suction required, but does not affect dissection
  3. = Moderate bleeding: Slightly compromises surgical field, frequent suction required
  4. = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction
  5. = Massive bleeding: Prevent dissection.
intraoperativel

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of Blood loss
Time Frame: intraoperative
intraoperative
Duration of surgery
Time Frame: the duration from induction of anesthesia till extubation
the duration from induction of anesthesia till extubation
Avoidance of postoperative nasal packing
Time Frame: immediately after the surgey
if the patient can be spared from postoperatiove nasal pack inserted for controllling bleeding
immediately after the surgey
Intra-operative and Postoperative complications
Time Frame: intraoperative and 24 hours postoperative
Complications such as nausea, vomiting, hypotnsion, hypertension, hemorraghic or thrombotic manifestations for 24 hours
intraoperative and 24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

April 22, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 22, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27111344

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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