Adrenaline Solution Irrigation and Bleeding During Sinus Surgery

Jordan University of Science and Technology

Status and phase: Completed; Phase 1

Conditions: Chronic Rhinosinusitis (Diagnosis)

Treatments: Drug: Adrenaline saline irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT04551703

221

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Adrenaline saline irrigation

Experimental group

Description:

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

Treatment:

Drug: Adrenaline saline irrigation

Normal saline irrigation

No Intervention group

Description:

Normal saline bag will be used for irrigation during the procedure