Adrenaline Solution Irrigation and Bleeding During Sinus Surgery
Condition: Chronic Rhinosinusitis (Diagnosis)
MeSH terms: Sinusitis; Chronic Disease
Study type: Interventional
Phase: Phase 1

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
    

Intervention name(s): Adrenaline saline irrigation
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Epinephrine saline irrigation
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will randomize into two groups based on computer generating numbers. Group 1 will have the usual method of irrigation with normal saline during surgery whereas group 2 have irrigation with 1:100 000 adrenaline in normal saline. The solution will be prepared by the senior resident through 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. The investigators who collected the data will be blinded to the content of both preparations. Irrigation with either solution will be used during the procedure through a 20 mL syringe attached to an olive tip long curved suction.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Sinusitis; Nasal Polyp; Endoscopic Sinus Surgery; Adrenaline