NebulizationPhase 4NCT06777966
Nebulized Versus Intravenous Tranexamic Acid on Surgical Field Quality in Patients Undergoing Endoscopic Sinus Surgeries
A Phase 4 study testing nebulized tranexamic acid and intravenous tranexamic acid in people with Nebulization and Intravenous, run by Cairo University at 1 site in Egypt.
Trial summary
Intraoperative bleeding is one of the vital problems for anesthesiologists and surgeons, during endoscopic nasal surgery; where the surgical field is very limited and surrounded by vital structures. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nebulization, Intravenous, Surgical Field
- What is being tested?
- nebulized tranexamic acid and intravenous tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jan 2025to 10 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years.
- American Society of Anesthesiologists (ASA) class I and II patients.
- Endoscopic sinus surgeries under general anesthesia.
Who cannot join
- Patient's refusal.
- American Society of Anesthesiologists (ASA) class III or IV patients.
- Underlying uncontrolled hypertension.
- Known history bleeding disorder.
- Patients on anticoagulant therapy.
- Allergy to any of the drugs utilized in this study.
- History of nonsteroidal anti-inflammatory drugs within 48 hours of scheduled surgery.
- Inadvertent intra-operative vascular injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Nebulized Versus Intravenous Tranexamic Acid on Surgical Field Quality in Patients Undergoing Endoscopic Sinus Surgeries: a Randomized Controlled Comparative Study
Intraoperative bleeding is one of the vital problems for anesthesiologists and surgeons, during endoscopic nasal surgery; where the surgical field is very limited and surrounded by vital structures. The tinniest amount of blood in such surgical field can obscure the anatomy and clog the tip of the endoscope, requiring repeated irrigations and suctioning; both of which have traumatic effects on the friable nasal mucosa. Anesthetic techniques to minimize bleeding during endoscopic nasal surgery are of primary importance for a safe and effective procedure, reducing operative time and shortening post-operative recovery.
Good surgical conditions could be achieved with systemic, topical, or regional anesthetic techniques. The use of topical and regional techniques has been gaining popularity in recent years as an alternative to the administration of heavy premedication, high narcotic doses, intravenous lignocaine, clonidine, calcium channel blockers, sodium nitroprusside, beta-adrenergic blockers, and magnesium sulfate, which may produce a lack of alertness, respiratory depression, hypoxia, nausea and vomiting, and delayed recovery.
Read more
Recent studies have shown that the use of tranexamic acid could be a safe and effective management option for hemostasis in a wide range of specialties. Tranexamic acid (TXA) is a synthetic lysine derivative that blocks the lysine binding site on plasminogen, thus inactivating its conversion to plasmin and hence attenuating its fibrinolysis effects. When given as a one-time operative systemic dose, it can reduce intraoperative surgical blood loss. More recently, it has been used in its nebulized or topical form to treat bleeding in anatomically sequestered areas. Its use has been described for epistaxis, cancer-related hemoptysis, and post-tonsillectomy bleeding. Though systemic doses of tranexamic acid have proven their efficiency in reducing intraoperative bleeding, other forms of administration have not been widely researched. The use of nebulized form is expected to provide a targeted route and localized effect with reduced systemic side effects. Adverse effects of systemic administration of tranexamic acid include seizures, nausea, vomiting, diarrhea, pulmonary embolism, deep vein thrombosis, anaphylaxis, and other visual disturbance.
The purpose of this study was to assess the effect of pre-emptive nebulized tranexamic acid versus intravenous tranexamic acid on endoscopic visualization and bleeding rate during endoscopic sinus surgeries.
- Conditions
- Nebulization, Intravenous, Surgical Field, Endoscopic Sinus Surgeries
- Being tested
- nebulized tranexamic acid, intravenous tranexamic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nebulized tranexamic acidDrug
patients will receive a preoperative nebulizer session of 500 mg of tranexamic acid. To ensure the blinding of the participating anesthetist and patient, patients in this group will receive an intravenous drip of 100 ml of 0.9% normal saline.
intravenous tranexamic acidDrug
patients will receive a preoperative intravenous drip of TXA at a dose of 15 mg/kg in 100 ml of normal saline. To ensure blinding this group patients will receive 5 ml of 0.9% normal saline nebulizer session.
| Study group | Role | What they receive |
|---|---|---|
| Nebulized group | Active comparator | patients will receive nebulized tranexamic acid Receives: Drug: nebulized tranexamic acid |
| Intravenous group | Active comparator | patients will receive intravenous tranexamic acid Receives: Drug: intravenous tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean Wormald intraoperative surgical field grading
The mean value of Wormald intraoperative surgical field grading throughout the intraoperative period, where 0 means no bleeding and 10 means severe bleeding with nasal cavity filling rapidly
Measured: 5 hours
Secondary outcomes (6)
Total blood loss
calculated by measuring the volume of the blood in the suction reservoir minus the normal saline used to wash the surgical field
Measured: 5 hours
Bleeding rate
calculated as the total blood loss divided by the surgical time
Measured: 5 hours
Operation time
Time starting from induction of anesthesia till completion of the surgical procedure
Measured: 5 hours
Postoperative complications
nausea, vomiting, anaphylaxis, visual impairment, seizure, venous thromboembolism
Measured: 24 hours
postoperative nasal bleeding
Incidence of postoperative nasal bleeding
Measured: 48 hours
postoperative intervention
Incidence of the need for postoperative intervention to control nasal bleeding
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start24 Jan 2025
- Primary completion30 Jul 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NebulizationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Mohammed Assem Nawwar, Cairo University
- Investigators
- Nevan M Abbas Elmekawy, M.D., Study chair, Cairo UniversityTamer M Khair, M.D., Study director, Cairo UniversityKareem MA Nawwar, M.D., Study director, Cairo UniversityNadia E M Gaballah, M.Sc., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777966
- Sponsor's protocol ID
- MD-206-2024
- Status last verified
- Jul 2026
- First submitted
- 11 Jan 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Nebulized Versus Intravenous Tranexamic Acid on Surgical Field Quality in Patients Undergoing Endoscopic Sinus Surgeries: a Randomized Controlled Comparative Study
- ClinicalTrials.gov ID
- NCT06777966
- Acronym / sponsor ID
- MD-206-2024
- Conditions
- Nebulization, Intravenous, Surgical Field, Endoscopic Sinus Surgeries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intraoperative bleeding is one of the vital problems for anesthesiologists and surgeons, during endoscopic nasal surgery; where the surgical field is very limited and surrounded by vital structures. The tinniest amount of blood in such surgical field can obscure the anatomy and clog the tip of the endoscope, requiring repeated irrigations and suctioning; both of which have traumatic effects on the friable nasal mucosa. Anesthetic techniques to minimize bleeding during endoscopic nasal surgery are of primary importance for a safe and effective procedure, reducing operative time and shortening post-operative recovery.
Good surgical conditions could be achieved with systemic, topical, or regional anesthetic techniques. The use of topical and regional techniques has been gaining popularity in recent years as an alternative to the administration of heavy premedication, high narcotic doses, intravenous lignocaine, clonidine, calcium channel blockers, sodium nitroprusside, beta-adrenergic blockers, and magnesium sulfate, which may produce a lack of alertness, respiratory depression, hypoxia, nausea and vomiting, and delayed recovery.
Recent studies have shown that the use of tranexamic acid could be a safe and effective management option for hemostasis in a wide range of specialties. Tranexamic acid (TXA) is a synthetic lysine derivative that blocks the lysine binding site on plasminogen, thus inactivating its conversion to plasmin and hence attenuating its fibrinolysis effects. When given as a one-time operative systemic dose, it can reduce intraoperative surgical blood loss. More recently, it has been used in its nebulized or topical form to treat bleeding in anatomically sequestered areas. Its use has been described for epistaxis, cancer-related hemoptysis, and post-tonsillectomy bleeding. Though systemic doses of tranexamic acid have proven their efficiency in reducing intraoperative bleeding, other forms of administration have not been widely researched. The use of nebulized form is expected to provide a targeted route and localized effect with reduced systemic side effects. Adverse effects of systemic administration of tranexamic acid include seizures, nausea, vomiting, diarrhea, pulmonary embolism, deep vein thrombosis, anaphylaxis, and other visual disturbance.
The purpose of this study was to assess the effect of pre-emptive nebulized tranexamic acid versus intravenous tranexamic acid on endoscopic visualization and bleeding rate during endoscopic sinus surgeries.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized group | Active comparator | Drug: nebulized tranexamic acidpatients will receive nebulized tranexamic acid |
| Intravenous group | Active comparator | Drug: intravenous tranexamic acidpatients will receive intravenous tranexamic acid |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 60 years.
- American Society of Anesthesiologists (ASA) class I and II patients.
- Endoscopic sinus surgeries under general anesthesia.
Key exclusion criteria (8 listed)
- Patient's refusal.
- American Society of Anesthesiologists (ASA) class III or IV patients.
- Underlying uncontrolled hypertension.
- Known history bleeding disorder.
- Patients on anticoagulant therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nebulized tranexamic acidpatients will receive a preoperative nebulizer session of 500 mg of tranexamic acid. To ensure the blinding of the participating anesthetist and patient, patients in this group will receive an intravenous drip of 100 ml of 0.9% normal saline. | Drug | Nebulized group |
| intravenous tranexamic acidpatients will receive a preoperative intravenous drip of TXA at a dose of 15 mg/kg in 100 ml of normal saline. To ensure blinding this group patients will receive 5 ml of 0.9% normal saline nebulizer session. | Drug | Intravenous group |
Primary outcome
The mean Wormald intraoperative surgical field grading
Time frame: 5 hours
The mean value of Wormald intraoperative surgical field grading throughout the intraoperative period, where 0 means no bleeding and 10 means severe bleeding with nasal cavity filling rapidly
6 secondary outcomes
Total blood loss
Time frame: 5 hours
Bleeding rate
Time frame: 5 hours
Operation time
Time frame: 5 hours
Postoperative complications
Time frame: 24 hours
postoperative nasal bleeding
Time frame: 48 hours
postoperative intervention
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nevan M Abbas Elmekawy, M.D. study chair
Cairo University
Tamer M Khair, M.D. study director
Cairo University
Kareem MA Nawwar, M.D. study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nebulized tranexamic acid and intravenous tranexamic acid in people with Nebulization and Intravenous, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean Wormald intraoperative surgical field grading (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.