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

Intraoperative Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05841251
• Other study ID #: 27111344
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2023
• Source: Assiut University
• Contact: Ahmed A Mohammed, M.D.
• Phone: 01060757593
• Email: ahmedfotoh86[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Intraoperative Bleeding

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical field scale	the intraoperative surgical site bleeding using the surgical field scale as follows: 0 = No bleeding; = Minimal bleeding: Not a surgical nuisance and no suction required; = Mild bleeding: Occasional suction required, but does not affect dissection; = Moderate bleeding: Slightly compromises surgical field, frequent suction required; = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction; = Massive bleeding: Prevent dissection.	intraoperativel
Secondary	Volume of Blood loss		intraoperative
Secondary	Duration of surgery		the duration from induction of anesthesia till extubation
Secondary	Avoidance of postoperative nasal packing	if the patient can be spared from postoperatiove nasal pack inserted for controllling bleeding	immediately after the surgey
Secondary	Intra-operative and Postoperative complications	Complications such as nausea, vomiting, hypotnsion, hypertension, hemorraghic or thrombotic manifestations for 24 hours	intraoperative and 24 hours postoperative