Clinical trial NCT06188052: Efficacy of Topical Versus Intravenous Tranexamic Acid in Controlling Blood Loss
Official title: Efficacy of Topical Versus Intravenous Tranexamic Acid in Controlling Blood Loss in Patients Undergoing:Total Laryngectomy With Neck Dissection. A Randomized Control Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: To Calculate Total Blood Loss Immediately Postoperative
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion criteria:

- Patients of either sex, aged between 18-70 years old, ASA physical status I, II undergoing total laryngectomy

Exclusion Criteria:

* Patients with coagulopathy, a history of thromboembolism or a history of tranexamic acid allergy or complication will be excluded.

Primary outcomes:
measure: To calculate total blood loss immediately postoperative and compare it in 3 groups To calculate total blood loss and compare 3 groups
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University hospitals
Study officials:
affiliation: Cairo University Hospitals
name: Dina M Mohamed, MD
role: PRINCIPAL_INVESTIGATOR
References: