After obtaining local ethical committee approval and written informed consent from the
patients, 90 adult patients of both sex, aged between 18 and 50 years, ASA I-II, scheduled
for elective functional endoscopic sinus surgery in Ain Shams University hospitals will be
enrolled in this randomized, controlled prospective double blinded study.
Exclusion criteria included; patients with uncontrolled hypertension or coronary artery
disease, anaemia, end stage renal failure, liver cirrhosis, patients with coagulopathy or
receiving drugs influencing blood coagulation, cerebrovascular thrombosis or history of
thrombotic events, pregnancy, known sensitivity to any of the study drug and patients'
refusal to participate in the study.
The surgeon will assess the degree of sinus involvement in each patient using the Lund-Mackay
scoring system. All the patients will be instructed to take prednisone 1 mg. kg-1 5 days
before surgery to reduce inflammation.
After applying basic monitors, all patients will be premedicated with midazolam 0.05 mg.kg -1
IV, ranitidine 50 mg IV and dexamethasone 10 mg IV, 15 min. prior to surgery.
In the operating room and after 5 min preoxygenation, general anesthesia will be conducted
using the same protocol for all patients: fentanyl 1 μg.Kg-1, propofol 2-2.5 mg.kg -1 and
atracurium 0.5 mg. Kg-1 to facilitate endotracheal intubation.
Anaesthesia will be maintained using isoflurane 1 -1.5% in oxygen and air mixture 1:1 and
atracurium 0.1 mg. Kg-1 every 30 mim. Positive pressure ventilation was set to maintain
normocapnia. Fentanyl bolus of 0.5 μg.Kg-1 to maintain MAP (60-70 mmHg), without exceeding a
total dose of 5 μg.Kg-1 for fast tracking and early extubation. Total dose of fentanyl will
be recorded.
A throat pack soaked with saline will be inserted in all patients to prevent blood from
reaching the gastrointestinal track. The surgeon will insert nasal pack (epinephrine 1/2000
soaked pack), Afterwards, he will inject 2 ml of epinephrine 1:100000 into the middle
turbinate and the junction of the middle turbinate to the lateral nasal wall. All patients
will be placed in the same position.
Patients will then be randomly and evenly assigned to one of the four groups, 30 patients
each.
Group I: patients will receive an intravenous dose of 15 mg.kg-1 of tranexamic acid in a 10
ml syringe. The irrigation fluid will be 400 ml of normal saline.
Group II: patients will receive intravenous dose of 10 ml normal saline in 10 ml syringe.
Irrigation fluid will be 400 ml of normal saline with 2 g of tranexamic acid added to it. If
more irrigation is needed, normal saline will be used.
Group III: patients will receive an intravenous dose of 15 mg.kg-1 of tranexamic acid in a 10
ml syringe. Irrigation fluid will be 400 ml of normal saline with 2 g of tranexamic acid
added to it. If more irrigation is needed, normal saline will be used.
Group IV (control): patients will receive intravenous dose of 10 ml normal saline in 10 ml
syringe. The irrigation fluid will be 400 ml of normal saline.
Randomization was done using computer generated list. A pharmacist will prepare the drugs, as
well as the irrigation fluid, which will only have the patient's number on them. In this way,
the anaesthetist and the surgeon will be blinded to the study groups. The same surgeon
performed all the operations.
In all groups, if bleeding was uncontrollable and affecting the surgical field, loading dose
of esmolol 500 μg.Kg-1 will be started, followed by infusion of 100-300 mg.Kg-1.min-1. The
use and total dose of esmolol will be reported.
MAP and HR will recorded before induction of anaesthesia (baseline), immediately after
induction, and every 15 mim till completion of surgery.
Beside the maintenance fluid infusion, intraoperative blood loss will be compensated with
crystalloids in a ratio of 1:3.
Prothrombin time (PT), partial thromboplastin time (PTT) and complete blood count (CBC) will
be measured before surgery and 6 hours after surgery.
The surgeon will be asked to estimate the surgical field on a 5-point Boezaart scale
immediately at the end of the surgery (table 1).
Table 1: Surgical field quality based on Boezaart scale. 7 Grade Assessment 0 No bleeding.
Slight bleeding, no suction of blood required.
Slight bleeding, occasional suction required.
Slight bleeding, frequent suction required. Bleeding threatens surgical field few
seconds after suction is removed.
Moderate bleeding, frequent suction required. Bleeding threatens surgical field directly
after suction is removed.
Severe bleeding, constant suction required. Bleeding appears faster than can be removed
by suction. Surgical field severely threatened and surgery not possible
The incidence of postoperative complications including; epistaxis, nausea, vomiting and pain
(using VAS) will be evaluated in the PACU.