Evaluation of the effect of Intravenous Desmopressin, Tranexamic Acid, and their combination on intra-operative bleeding during functional endoscopic sinus surgery of adults

Assessing the effect of Intravenous Desmopressin, Tranexamic Acid, and their combination on intra-operative bleeding during functional endoscopic sinus surgery in adults

prospective randomized double-blind clinical trial

The study uses double-blind randomization. Participants are assigned to groups using sealed, opaque envelopes, ensuring neither participants nor investigators know the group assignments. This approach aims to reduce bias and improve study reliability.

The study includes adults aged 18-65 undergoing their first bilateral FESS for chronic rhinosinusitis with polyps. Eligible patients must have normal preoperative tests (platelet count, PT, PTT, INR, hemoglobin, BUN, creatinine, sodium, potassium) and be classified as ASA I or II. Excluded are those with Wegener's disease, sarcoidosis, sinonasal cancer, bleeding disorders, allergies to TXA/DDAVP, thromboembolic diseases, seizure history, renal impairment, DIC or other coagulopathies, color vision disorders, pregnant/breastfeeding, heart failure/fluid restriction conditions, hyponatremia/history, revision surgeries, uncontrolled hypertension, significant coronary artery disease or arrhythmias.

Patients will randomly assign to one of the three study groups: patients in the DDAVP group will receive 0.3 μg/kg of IV DDAVP preoperatively, 15 mg/kg of IV TXA in the TXA group, and 0.3 μg/kg of IV DDAVP + 15 mg/kg of IV TXA in the combination group.

Intraoperatively, the duration of surgery (minutes), and total suctioned blood volume (ml), will be recorded. We are also going to document, the surgical quality field score. Post-operatively any significant adverse .effects within 3 days including nausea, vomiting, epistaxis, and headache will be reported

The randomization method for this double-blinded randomized clinical trial will be conducted using computer-generated random numbers. The assignment of participants to the study groups will be performed in a randomized manner to ensure equal distribution among the groups. The randomization process will be carried out by an individual who is not directly involved in the recruitment or assessment of participants. Once informed consent is obtained from eligible participants, they will be assigned a unique identification number. The randomization list will be generated using a computer program, which will allocate participants to one of the ..three study groups: DDAVP group, TXA group, or combination group

To ensure the integrity and validity of the study, a double-blind approach will be implemented, where both the participants and the research team will be blinded to the treatment assignments. The blinding method will involve the following measures: 1. Blinded Treatment Allocation: The assignment of participants to the three study groups (DDAVP group, TXA group, and combination group) will be performed using computer-generated random numbers by an independent researcher not involved in the data collection or analysis. The treatment allocation will be concealed from the participants, surgeons, anesthesiologist, and other members of the research team who are directly involved in patient care. 2. Identical Packaging and Labeling: The DDAVP and TXA medications will be prepared and packaged in identical containers with matching labels. The containers will be indistinguishable in appearance, ensuring that neither the participants nor the healthcare providers can differentiate between the treatments. 3. Blinded Administration: The medications (DDAVP and TXA) will be administered intravenously by a nurse or healthcare provider who is not directly involved in the data collection or analysis. The administration will be performed in a separate room away from the surgical area, ensuring that the surgical team remains unaware of the specific treatment being administered. 5. Blinded Data Collection and Analysis: The collection of intraoperative and postoperative data, will be performed by research personnel who are blinded to the treatment assignments. These individuals will not have access to the treatment information during data collection, thereby preventing any potential bias in data recording. 5. Unblinding Procedures: In the case of an emergency or if there is a medical necessity to reveal the treatment assignment for a specific participant, a separate unblinding procedure will be established. This procedure will outline .the steps to be followed to maintain the blinding integrity of the study while addressing the participant's needs

The data that support the findings of this study include study outcomes of the data gathering form.

The data will be available from Ali Faramarzi, upon reasonable request for journal peer-reviewers and editors during the publication process and for readers after publication upon reasonable request.

It will be available from Ali Faramarzi, upon reasonable request for journal peer-reviewers and editors during the publication process and for readers after publication upon reasonable request.

For reviewers of the journal for further review and for other researchers for future studies

Ali Faramarzi, MD, Otolaryngology Research Center, Khalili Hospital, Department of Otolaryngology, Shiraz University of Medical Sciences, Shiraz, Iran. Email: ali_faramarzi@sums.ac.ir

Reviewers and editors of the journal to whom the article was submitted. After the publication of the article, other researchers can send their request for access to the data for review by presenting their registered proposal to the plan administrators.