Intraoperative BleedingNCT05841251
Phenylephrine Versus Tranexamic Acid to Control Bleeding in Patients Undergoing Inferior Turbinoplasty by Coblation
A study testing Topical Phenylephrine Solution and intravenous tranexamic acid in people with Intraoperative Bleeding and Coblation Turbinoplasty, run by Assiut University.
Trial summary
Coblation is a unique method of delivering radio frequency energy to the soft tissue for applications in otolaryngology. It induces reduction of the inferior turbinate by vaporizing and destroying the soft erectile tissue. The volume reduction and tissue fibrosis are immediate and sustainable. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intraoperative Bleeding, Coblation Turbinoplasty
- What is being tested?
- Topical Phenylephrine Solution and intravenous tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 Dec 2023
- Phase
- Interventional
- 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
- American Society of Anesthesiologists (ASA) physical status I and II
- Scheduled patients for Coblation Turbinoplasty surgery with inferior turbinate hypertrophy
Who cannot join
- Known allergy to study drugs.
- History of coagulopathy or bleeding disorders.
- Patients with hypertension or ischemic heart disease.
- patients on anticoagulants, antiplatelets or NSAIDs
- history of deep vein thrombosis, stroke or peripheral vascular disease.
Trial locations and contacts
No sites are listed yet.
About this study
Coblation is a unique method of delivering radio frequency energy to the soft tissue for applications in otolaryngology. It induces reduction of the inferior turbinate by vaporizing and destroying the soft erectile tissue. The volume reduction and tissue fibrosis are immediate and sustainable. Bleeding from the vascular capillary beds of the sinonasal mucosa compromises the surgical field and increases operative time and risk of complications. In this study we try to assist hemostasis with a multifaceted approach, including use of topical vasoconstrictors "phenylephrine" and systemic antifibrinolytic agent "tranexamic acid".
- Conditions
- Intraoperative Bleeding, Coblation Turbinoplasty
- Being tested
- Topical Phenylephrine Solution, intravenous tranexamic acid
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Phenylephrine SolutionDrug
phenylephrine-soaked pack using the whole 5 ml of the solution provided with.5% phenylephrine will be applied after induction of surgery and intubation, 15 minutes before surgery. 100 ml of normal saline will be given.
intravenous tranexamic acidDrug
patients will receive intravenous Single dose of tranexamic acid 15 mg/kg in 100 mL normal saline over 10 minutes. Saline-soaked pack will be applied.
| Study group | Role | What they receive |
|---|---|---|
| phenylephrine | Active comparator | phenylephrine-soaked pack will be applied after induction of surgery and intubation. Receives: Drug: Topical Phenylephrine Solution |
| tranexamic acid | Active comparator | Single intravenous dose of tranexamic acid 15 mg/kg will be given in 100 mL normal saline over 10 minutes. Receives: Drug: intravenous tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical field scale
the intraoperative surgical site bleeding using the surgical field scale as follows: 0 = No bleeding
- = Minimal bleeding: Not a surgical nuisance and no suction required
- = Mild bleeding: Occasional suction required, but does not affect dissection
- = Moderate bleeding: Slightly compromises surgical field, frequent suction required
- = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction
- = Massive bleeding: Prevent dissection.
Measured: intraoperativel
Secondary outcomes (4)
Volume of Blood loss
Measured: intraoperative
Duration of surgery
Measured: the duration from induction of anesthesia till extubation
Avoidance of postoperative nasal packing
if the patient can be spared from postoperatiove nasal pack inserted for controllling bleeding
Measured: immediately after the surgey
Intra-operative and Postoperative complications
Complications such as nausea, vomiting, hypotnsion, hypertension, hemorraghic or thrombotic manifestations for 24 hours
Measured: intraoperative and 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative BleedingStudies of the same condition, open and under way.
- More trials run by Assiut 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Aboulfotouh Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841251
- Sponsor's protocol ID
- 27111344
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenylephrine Versus Tranexamic Acid to Control Bleeding in Patients Undergoing Inferior Turbinoplasty by Coblation
- ClinicalTrials.gov ID
- NCT05841251
- Acronym / sponsor ID
- 27111344
- Conditions
- Intraoperative Bleeding, Coblation Turbinoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 3 May 2023 (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.
Coblation is a unique method of delivering radio frequency energy to the soft tissue for applications in otolaryngology. It induces reduction of the inferior turbinate by vaporizing and destroying the soft erectile tissue. The volume reduction and tissue fibrosis are immediate and sustainable. Bleeding from the vascular capillary beds of the sinonasal mucosa compromises the surgical field and increases operative time and risk of complications. In this study we try to assist hemostasis with a multifaceted approach, including use of topical vasoconstrictors "phenylephrine" and systemic antifibrinolytic agent "tranexamic acid".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| phenylephrine | Active comparator | Drug: Topical Phenylephrine Solutionphenylephrine-soaked pack will be applied after induction of surgery and intubation. |
| tranexamic acid | Active comparator | Drug: intravenous tranexamic acidSingle intravenous dose of tranexamic acid 15 mg/kg will be given in 100 mL normal saline over 10 minutes. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I and II
- Scheduled patients for Coblation Turbinoplasty surgery with inferior turbinate hypertrophy
Key exclusion criteria (5 listed)
- Known allergy to study drugs.
- History of coagulopathy or bleeding disorders.
- Patients with hypertension or ischemic heart disease.
- patients on anticoagulants, antiplatelets or NSAIDs
- history of deep vein thrombosis, stroke or peripheral vascular disease.
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 |
|---|---|---|
| Topical Phenylephrine Solutionphenylephrine-soaked pack using the whole 5 ml of the solution provided with.5% phenylephrine will be applied after induction of surgery and intubation, 15 minutes before surgery. 100 ml of normal saline will be given. | Drug | phenylephrine |
| intravenous tranexamic acidpatients will receive intravenous Single dose of tranexamic acid 15 mg/kg in 100 mL normal saline over 10 minutes. Saline-soaked pack will be applied. | Drug | tranexamic acid |
Primary outcome
surgical field scale
Time frame: intraoperativel
the intraoperative surgical site bleeding using the surgical field scale as follows: 0 = No bleeding 1. = Minimal bleeding: Not a surgical nuisance and no suction required 2. = Mild bleeding: Occasional suction required, but does not affect dissection 3. = Moderate bleeding: Slightly compromises surgical field, frequent suction required 4. = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction 5. = Massive bleeding: Prevent dissection.
4 secondary outcomes
Volume of Blood loss
Time frame: intraoperative
Duration of surgery
Time frame: the duration from induction of anesthesia till extubation
Avoidance of postoperative nasal packing
Time frame: immediately after the surgey
Intra-operative and Postoperative complications
Time frame: intraoperative and 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Phenylephrine Solution and intravenous tranexamic acid in people with Intraoperative Bleeding and Coblation Turbinoplasty, run by Assiut University.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Mohammed, M.D. (01060757593, ahmedfotoh86@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical field scale (time frame: intraoperativel). 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 3 May 2023.