Nebulized Tranexamic Acid in Sinus Surgery
Primary Purpose
Bleeding Nose
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Tranexamic acid
Saline placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bleeding Nose
Eligibility Criteria
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.
Sites / Locations
- AssuitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Tranexamic acid 500 mg
Tranexamic acid 1gm
Saline placebo
Arm Description
Nebulized tranexamic acid 500 mg 15 minutes before operation
Nebulized tranexamic acid 1 gm 15 minutes before operation
Normal saline nebulization 15 minutes before operation
Outcomes
Primary Outcome Measures
the Modena Bleeding Score (MBS) assessing surgical field
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 Outcome Measures
HR
Heart rate beat/min
MBP
Mean blood pressure mmHg
Anesthetic consumption
Extra doses of fentanyl and propofol and sevoflurane>2
Postoperative complications
Recording any adverse effects to TXA e.g.nausea, vomiting and any visual disturbances
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04905901
Brief Title
Nebulized Tranexamic Acid in Sinus Surgery
Official Title
Does Nebulized Tranexamic Acid Affect Operative Field in Sinus Surgery? A Double Blind Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
March 20, 2024 (Anticipated)
Study Completion Date
March 25, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Nose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic acid 500 mg
Arm Type
Experimental
Arm Description
Nebulized tranexamic acid 500 mg 15 minutes before operation
Arm Title
Tranexamic acid 1gm
Arm Type
Experimental
Arm Description
Nebulized tranexamic acid 1 gm 15 minutes before operation
Arm Title
Saline placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline nebulization 15 minutes before operation
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
Cyclokapron
Intervention Description
Tranexamic acid nebulization 15 minutes before sinus surgery
Intervention Type
Other
Intervention Name(s)
Saline placebo
Intervention Description
Normal saline placebo nebulization 15 minutes before sinus surgery
Primary Outcome Measure Information:
Title
the Modena Bleeding Score (MBS) assessing surgical field
Description
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
Time Frame
After anesthesia induction to 60 minute
Secondary Outcome Measure Information:
Title
HR
Description
Heart rate beat/min
Time Frame
Intraoperative duration
Title
MBP
Description
Mean blood pressure mmHg
Time Frame
Intraoperative duration
Title
Anesthetic consumption
Description
Extra doses of fentanyl and propofol and sevoflurane>2
Time Frame
Anesthesia duration
Title
Postoperative complications
Description
Recording any adverse effects to TXA e.g.nausea, vomiting and any visual disturbances
Time Frame
After operation to 24 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Assuit
City
Assiut
State/Province
Assuit
ZIP/Postal Code
Assuit universi
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Soliman
Phone
01101266040
Email
omarmakram347@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Nebulized Tranexamic Acid in Sinus Surgery
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