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

NCT05841251 | Unknown

• 1 other identifier: 27111344
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• surgical field scale

  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 Outcomes (4)

• Volume of Blood loss

  intraoperative

• Duration of surgery

  the duration from induction of anesthesia till extubation

• Avoidance of postoperative nasal packing

  immediately after the surgey

• Intra-operative and Postoperative complications

  intraoperative and 24 hours postoperative

Study Arms (2)

phenylephrine

ACTIVE COMPARATOR

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

Drug: Topical Phenylephrine Solution

tranexamic acid

ACTIVE COMPARATOR

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

Drug: intravenous tranexamic acid

Interventions

Topical Phenylephrine Solution DRUG

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.

phenylephrine

intravenous tranexamic acid DRUG

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.

tranexamic acid

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I and II
• Scheduled patients for Coblation Turbinoplasty surgery with inferior turbinate hypertrophy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Central Study Contacts

Ahmed A Mohammed, M.D.

CONTACT

01060757593; ahmedfotoh86@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Anesthesia and icu

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 3, 2023
• Study Start: May 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-04