Bleeding Nose
Conditions
Brief summary
The results of several recent studies on endoscopic sinus surgery through topical administration of tranexamic acid are encouraging in terms of the efficacy of tranexamic acid for intraoperative bleeding and other pathological conditions.The purpose of this study is to analyze the efficacy of nebulized tranexamic acid to improve the surgeon and patient experiences of sinus surgery and know the effective and safe dose of nebulized tranexamic acid.
Detailed description
A written informed consent will be taken from the patients.The study involved adults of either sexes (age 18-65 years) of ASA I-II who will be listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia, with normal accepted coagulation profile and hematocrit value ≥30 %. Excluded from the study patients with chronic renal failure, liver cirrhosis, bleeding disorders, current anticoagulant therapy, pregnancy or breastfeeding, impaired color vision, severe vascular ischemia, history of venous thrombosis, pulmonary embolism, long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before surgery, a hemoglobin (HB) concentration \<10 mg/dl or allergy to TXA. Randomization: A random number sequence created by an internet website (http://www. random.org) will be used for patients' allocation. The random number sequence was retained in closed opaque envelopes released the day of the surgery by an independent physician not involved in the study. Patients will be assigned randomly to three groups (30 subjects each); saline placebo (Group S) and two different doses of preemptive nebulized tranexamic acid (Group T1) and (Group T2).To keep blinding, Group S will receive 2 sessions of nebulization each by 5 ml saline. Group T1 will receive one nebulization session 500 mg tranexamic acid (5 ml) and another one by 5 ml saline. Group T2 will receive 2 nebulization sessions each by 500 mg tranexamic acid (each by 5 ml)
Interventions
DRUGTranexamic acid
Tranexamic acid nebulization 15 minutes before sinus surgery
OTHERSaline placebo
Normal saline placebo nebulization 15 minutes before sinus surgery
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Either sexes (age 18-65 years) of ASA I-II who are listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia * normal accepted coagulation profile and hematocrit value ≥30
Exclusion criteria
* chronic renal failure * liver cirrhosis * bleeding disorders * current anticoagulant therapy * pregnancy or breastfeeding * impaired color vision * severe vascular ischemia * history of venous thrombosis, pulmonary embolism * long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before surgery * hemoglobin (HB) concentration \<10 mg/dl \_allergy to TXA.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Modena Bleeding Score (MBS) assessing surgical field | After anesthesia induction to 60 minute | 1= No bleeding, 2=Bleeding easily controlled by suctioning, washing or packing without any significant modification or slowing of surgical procedure, 3=Bleeding slowing surgical procedure, 4=Most of the maneuvers dedicated to bleeding control and 5=Bleeding that prevents every surgical procedure except those dedicated to bleeding control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HR | Intraoperative duration | Heart rate beat/min |
| MBP | Intraoperative duration | Mean blood pressure mmHg |
| Anesthetic consumption | Anesthesia duration | Extra doses of fentanyl and propofol and sevoflurane\>2 |
| Postoperative complications | After operation to 24 hour | Recording any adverse effects to TXA e.g.nausea, vomiting and any visual disturbances |
Countries
Egypt
Outcome results
None listed