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Total laryngectomy with bilateral block neck dissection is considered one of the major head and neck surgeries. Intraoperative bleeding is considered a risk factor for this operation specially that the population of this operation are elder with multiple comorbidities. Intravenous administration of tranexamic acid reduces bleeding during surgery.We design this study aiming to prove the role of topical tranexamic acid in controlling the intraoperative bleeding in patients undergoing total laryngectomy operation avoiding the risk of intravenous administration.
45 patients undergoing total laryngectomy operation will be enrolled in this study. The patients will be divided into 3 equal groups, 15 patients in each group. Group (A), tranexamic acid will be given 1 hr preoperatively. Group (B), topical tranexamic acid will be given as an irrigation to the surgical site. Group (C), control group.One hour preoperatively, a wide bore cannula will be inserted to all patients. Tranexamic acid 1mg/kg will be given intravenously to patients in group (A). Normal saline will be given to Group (B) and group (C) .On arrival to the operating room, a pulse oximetry, continuous electrocardiogram (ECG), and non-invasive blood pressure measurement device will be connected to the patient. Pre-medications will be given; metoclopramide (10mg) and dexamethasone (8mg) preoperatively. Induction will be done by sevoflurane, propofol 1mg/ kg, succinyl choline 0.5mg/kg. After intubation, fentanyl 2mic/kg and atracurium 0.5mg/kg will be given , followed by 0.8 mg/kg Morphine sulphate . Anesthesia will be maintained by isoflurane 1.5% and atracurium 0.1mg/kg/ 30min. After flap elevation ( using local infiltraton of epinephrine 1/100000), the surgical site will be irrigated by 40 ml of tranexamic acid 2mg/kg dissolved in 200ml normal saline every 1 hour for the first 5 hours in group (B), and by normal saline in group (A) and group (C).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group (A), tranexamic acid IV | Active Comparator | tranexamic acid will be given 1 hr preoperatively as 1mg/kg intravenously |
|
| Group (B), topical tranexamic acid | Active Comparator | topical tranexamic acid will be given as an irrigation by 40 ml of tranexamic acid 2mg/kg dissolved in 200ml to the surgical site every 1 hour for the first 5 hours . |
|
| Group (C), control group. | Placebo Comparator | Saline will be given intravenously instead of tranexamic acid And irrigation with Saline instead of tranexamic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | Comparing the 3 groups regarding intraoperative bleeding, hemoglobin level pre and postoperative and the need of blood transfusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| To calculate total blood loss immediately postoperative and compare it in 3 groups To calculate total blood loss and compare 3 groups | Intraoperative bleeding will be assessed and blood loss will be measured in ml ( amount of blood in canister and sponges) | Intraoperative |
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Inclusion criteria:
- Patients of either sex, aged between 18-70 years old, ASA physical status I, II undergoing total laryngectomy
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dina M Mohamed, Lecturer | Contact | 01005249134 | MD | Dinamahmoud@kasralainy.edu.eg |
| Amr H Sayed, professor | Contact | 01069338998 | MD | amr.hussein.sayed@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dina M Mohamed, MD | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University hospitals | Recruiting | Cairo | 11559 | Egypt |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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All procedures will be performed by the same team, all of whom will be blind to the group assignment (except for the resident who will prepare the drug formula whether intravenous or the topical irrigation and will be responsible for randomization and drug masking using closed envelope randomization)