Adrenaline Solution Irrigation and Bleeding During Sinus Surgery

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.

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Key information

Conditions

Chronic Rhinosinusitis (Diagnosis) Disease Infections Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases Respiratory Tract Infections Sinusitis

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adrenaline saline irrigation

Drug

The surgical field is flushed with 20 cc of Adrenaline saline irrigation. This is in contrast to the standard of care, normal saline irrigation.

Other names: Epinephrine saline irrigation

Primary outcomes

The Boezaart intraoperative surgical field scale

Time frame: 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 outcomes

Volume of total blood loss

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

The Effect of Intranasal Irrigation With Adrenaline Solution on Intraoperative Visualization and Bleeding During Functional Endoscopic Sinus Surgery

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Sep 16, 2020
Registry last updated: Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed