Effect of addition of topical tranexamic acid to standard topical adrenaline in reduction of intraoperative blood loss in functional endoscopic sinus surgery: A Randomized controlled trial.

This study will be conducted as a randomized controlled trial to evaluate the effect of addition of topical tranexamic acid to standard adrenaline on intraoperative blood loss during Functional Endoscopic Sinus Surgery (FESS) in adult patients with chronic rhinosinusitis. The study design adheres to the principles of the CONSORT statement to ensure rigorous methodology and transparent reporting.

STUDY POPULATION

Inclusion Criteria

Adult patients aged 18 to 65 years undergoing FESS for chronic rhinosinusitis defined by EPOS 2020 criteria who have undergone optimum medical treatment.

Exclusion Criteria

History of previous sinus or nasal surgery

Known bleeding disorders or coagulopathies

Use of medications affecting bleeding or coagulation within 7 days prior to surgery

Active systemic infection

Pregnancy or lactation

Known allergy or contraindication to tranexamic acid or adrenaline

Patients with high blood pressure systolic greater than 140 mmHg and or diastolic greater than 90 mmHg

SAMPLE SIZE – 38 in each group, total 76

Patient recruitment

Patients will be recruited from the outpatient department of ENT based on history, clinical examination, and diagnostic nasal endoscopy according to EPOS 2020. Surgery is considered in adult patients with uncomplicated CRS when the CT Lund Mackay score is 1 or more and there has been a minimum trial of at least eight weeks duration of a topical intranasal corticosteroid plus a short course of systemic corticosteroid in CRSwNP or either a short course of a broad spectrum or culture directed systemic antibiotic or the use of a prolonged course of systemic low dose anti inflammatory antibiotic in CRSsNP with a post treatment total SNOT 22 score of 20 or more. Informed consent will be obtained from all participants prior to enrolment in the study.

Preoperatively, the degree of sinus involvement will be assessed using the SNOT 22 scoring and Lund Mackay scoring system based on CT scans of the paranasal sinuses.

Randomization and Allocation Concealment

Eligible patients will be assigned to either the tranexamic acid plus adrenaline group Group A or the adrenaline alone control group Group B using block randomization. Block randomization will be performed with block size being 4. In each block there will be 4 participants, 2 from each group. When new participants are recruited, they are assigned to a block. For each new block, a pre generated permutation is randomly chosen and participants within that block are then assigned to the treatment groups according to that chosen sequence. Allocation concealment will be ensured using the SNOSE method with sequentially numbered sealed opaque envelopes.

Envelope Preparation

Prior to the commencement of patient recruitment, a statistician will prepare the envelopes. Using the computer generated randomization sequence, the statistician will place the assigned treatment group A or B on a piece of paper inside each envelope. Envelopes will be sequentially numbered on the outside to ensure that they are opened in the correct order. The envelopes will be sealed and opaque to prevent disclosure of the contents.

Envelope Storage

The prepared envelopes will be stored in a locked cabinet within the operation theatre complex in a location inaccessible to the surgical team and study investigators. Access to the cabinet will be restricted to the designated senior operation theatre nurse.

Envelope Dispensing

At the time of surgery, after the patient is prepped and positioned, the assisting operation theatre nursing staff will retrieve the next sequentially numbered envelope from the locked cabinet. The assisting operation theatre nursing staff will hand the envelope to the scrub nurse, who will open the envelope and prepare the assigned treatment according to the group allocation within. The assisting operation theatre nursing staff will document the envelope number and patient’s study ID in a logbook to maintain a record of envelope usage.

Blinding

Patients, surgeons performing the FESS, and personnel assessing outcomes will be blinded to the treatment allocation. The solutions will be prepared by a designated scrub nurse using identical containers and labeling to ensure indistinguishability.

Anaesthesia Protocol

Standard general anesthesia protocol with endotracheal intubation will be followed. Anesthesia will be induced with midazolam 1 mg IV, fentanyl 2 mcg per kg, and propofol 2 to 2.5 mg per kg and maintained on oxygen plus air plus sevoflurane with intermittent dose of atracurium. Mean arterial pressure will be maintained at 60 to 70 mmHg. If mean arterial pressure is greater than 70 mmHg then NTG drip 0.25 to 0.5 mcg per kg per minute will be given till mean arterial pressure is less than 70 mmHg. If mean arterial pressure is less than 60 mmHg or greater than 70 mmHg, the sample will be excluded from further analysis. Both groups will receive 500 mg IV tranexamic acid as a protocol. If need of additional tranexamic acid or any other hypotensive measures is required, it will be recorded.

Intervention

The surgery will be done under general anesthesia. A throat pack will be placed in all patients.

Control Group

After intubation, 2 vials of 1:1000 concentration adrenaline diluted in 20 ml of normal saline will be applied topically using patties. Three patties will be placed in each nasal cavity for 10 minutes prior to surgery.

Intervention Group

After intubation, 1 vial of 500 mg per ml concentration tranexamic acid added to 2 vials of 1:1000 concentration adrenaline diluted in 20 ml of normal saline will be applied topically using patties. Three patties will be placed in each nasal cavity for 10 minutes prior to surgery.