Adrenaline Solution Irrigation and Bleeding During Sinus Surgery

Phase 1

Completed

• Conditions: Chronic Rhinosinusitis (Diagnosis)
• Interventions: Drug: Adrenaline saline irrigation

• Registration Number: NCT04551703
• Lead Sponsor: Jordan University of Science and Technology

Brief Summary

Intranasal irrigation with normal saline is routinely used in sinus surgery to clean the tip of the nasal endoscope and clear the surgical field from blood. The purpose of this study is to evaluate the difference in the surgical visualization, surgeon satisfaction and total blood loss when intraoperative irrigation was performed with a solution of normal saline with adrenaline as compared to irrigation with normal saline alone in FESS.

Detailed Description

Functional Endoscopic Sinus Surgery (FESS) is a common, effective and minimally invasive surgical procedure indicated mainly to treat medically resistant chronic rhinosinusitis with or without nasal polyposis.

The surgery is often performed under general anesthesia and proceeds in anatomically based surgical landmarks steps to facilitate drainage and ventilation of the paranasal sinuses. As any other endoscopic and laparoscopic procedures the operation requires dry surgical field to ensure accurate identification and visualization of structures and smooth surgical dissection progression. Intranasal bleeding during FESS will increase time of surgery and perioperative complications. Also it could affect healing process, increase adhesion formation and lengthening recovery period .

Different methods and maneuvers have been described in the literature to reduce intra-operative bleeding during sinus surgery. These include: elevation of the patient's head, the use of bipolar cautery and powered instruments; premedication with beta blockers; a controlled hypotensive anesthesia technique; total intravenous anesthesia, topical hemostatic biomaterials and local application of vasoconstrictors.

Adrenaline is one of the most commonly used topical vasoconstrective agent. Because systemic absorption of infiltrated adrenaline can give rise to a sudden increase in blood levels of catecholamine compared to topical instillation and thus various life-threatening complications, such as : cardiac arrhythmia, cardiac arrest, cardiomyopathy, pulmonary edema, and central retinal artery occlusion; many surgeons prefer to use instillation of adrenaline over infiltration in FESS

Study Timeline

• Study Start: 2016-07-01
• Primary Completion: 2020-08-11
• Study Completion: 2020-08-11
• Study First Submitted: 2020-08-23
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-15
• Last Update Submitted: 2020-09-15
• Study First Posted: 2020-09-16
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with American Society of Anesthesiologist (ASA) classification <2
• Patients with chronic with or without nasal polyposis refractory to medical treatment

Exclusion Criteria

• Patients with a history of of bleeding diathesis
• Patients with severe ischemic heart disease , pulmonary and renal disease
• Patients with tumours or vascular anomalies
• Patients with cystic fibrosis, allergic fungal sinusitis and granulomatous disorders
• Patients who are unable to speak, read and write English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adrenaline saline irrigation	Adrenaline saline irrigation	Adrenaline saline irrigation will be prepared by adding one ampule of 0.1 percent adrenaline in one liter bag of normal saline, which made the adrenaline concentration in the solution 1:100 000

Primary Outcome Measures

Name	Time	Method
The Boezaart intraoperative surgical field scale	2 hours	The Boezaart intra-operative surgical field scale will be used to grade the level of bleeding during surgery. This 0 to 5-point scale will be used to outline the amount of suction required to rid the area of blood disrupting vision. A score of 0 is given for an area with no bleeding, 1 for slight bleeding with no suction required, 2 for slight bleeding requiring suction, 3 for moderate bleeding which improves for several seconds once suction has occurred, 4 for moderate bleeding which restarts directly after suctioning and 5 for severe bleeding which occurs faster then can be removed

Secondary Outcome Measures

Name	Time	Method
Volume of total blood loss	The volume of blood loss will be measured every 30 minutes from the start of surgery for the duration of 2 hours	Total blood loss will be calculated and measured over the duration of surgery.