Oral SurgeryPhase 2NCT06789549
Epinephrine Nasal Drops for Epistaxis During Nasal Intubation
A Phase 2 study testing epinephrine nasal drops and oxymetazoline nasal drops in people with Oral Surgery, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
Epistaxis is the most common complication of nasotracheal intubation. Incidence of epistaxis during nasotracheal intubation ranges from 22% to 80%. Epistaxis during nasotracheal intubation can lead to several complications such as nasal discomfort, airway obstruction, and blood aspiration. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Oral Surgery
- What is being tested?
- epinephrine nasal drops and oxymetazoline nasal drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2024to 1 Apr 2024
- Phase
- Phase 2
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- underwent oral surgery with nasotracheal intubation
- aged 18-50 years
- ASA (American Society of Anesthesiologists) physical status of 1-2.
Who cannot join
- allergy to the medications used
- nasal congestion, nasal polyps, allergic rhinitis
- hypertension and use of antihypertensive medications,
- abnormal coagulation factors, receiving antithrombotic and anticoagulant therapy,
- difficult intubation with a LEMON score ≥4,
- a history of nasal surgery or nasal trauma,
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- pregnancy,
- heart abnormalities,
- ischemic heart disease or arrhythmias,
- symptoms of acute respiratory infection perioperatively,
- liver and kidney function abnormalities, and
- a history of spontaneous epistaxis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Efficacy of Epinephrine Nasal Drops and Oxymetazoline Nasal Drops in Reducing Epistaxis During Nasal Intubation: A Randomized Controlled Trial
Epistaxis is the most common complication of nasotracheal intubation. Incidence of epistaxis during nasotracheal intubation ranges from 22% to 80%. Epistaxis during nasotracheal intubation can lead to several complications such as nasal discomfort, airway obstruction, and blood aspiration. The most commonly used and available topical vasoconstrictor in drop form is oxymetazoline. However, oxymetazoline may not always be available in some hospitals, so epinephrine can be used as an alternative nasal decongestant to reduce the incidence of epistaxis during nasotracheal intubation.
Read the detailed description
Epistaxis associated with nasotracheal intubation can be from blood-tinged mucus to massive bleeding. Epistaxis during nasotracheal intubation can cause excessive force during the procedure, use of an endotracheal tube (ETT) larger than the nasal cavity, repeated intubation attempts, and abnormalities in the anatomy of the nose or nasopharynx. Epistaxis during nasotracheal intubation can lead to several complications such as nasal discomfort, airway obstruction, and blood aspiration.
Topical vasoconstrictors such as oxymetazoline are used to reduce the incidence and severity of epistaxis caused by nasotracheal intubation. Oxymetazoline nasal drops before nasotracheal intubation significantly increases the intranasal diameter and causes vasoconstriction of blood vessels, thereby reducing bleeding and damage to the nasal mucosa.
Epinephrine can be used as an alternative nasal decongestant to reduce the incidence of epistaxis during nasotracheal intubation. Administering 1 mL of 0.1% topical epinephrine reduces 25% nasal mucosal volume and decreases 37% blood flow, thereby providing nasal cavity expansion with lower hemodynamic and systemic effects.
Currently, there exists a lack of empirical research regarding the utilization of epinephrine drops for the prophylaxis of epistaxis in the context of nasotracheal intubation. Given this gap in the literature, the objective of this investigation is to conduct a comparative analysis between the application of 0.1% epinephrine nasal drops and 0.05% oxymetazoline nasal drops for the prevention of epistaxis during nasotracheal intubation procedures for oral surgery.
- Conditions
- Oral Surgery
- Being tested
- epinephrine nasal drops, oxymetazoline nasal drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epinephrine nasal dropsDrug
Also called Epinephrine 1mg/ml - Pt. Pharos Tbk
Patients in experimental arms received 1 mL of 0.1% epinephrine nasal drops before nasotracheal intubation
oxymetazoline nasal dropsDrug
Also called Oxymetazoline - Iliadin nasal drop 0,05%
Patients in experimental arms received 1 mL of 0.1% oxymetazoline nasal drops before nasotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| epinephrine nasal drops | Experimental | twenty patients was be administered randomly 1 mL of 0.1% epinephrine nasal drops. Receives: Drug: epinephrine nasal drops |
| oxymetazoline nasal drops | Active comparator | twenty patients was be administered randomly receives 1 mL of 0.05% oxymetazoline nasal drops Receives: Drug: oxymetazoline nasal drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epistaxis
The level of epistaxis was assessed during laryngoscopy intubation, 10 minutes after intubation using laryngoscopy, and immediately after extubation.
The degree of epistaxis was graded on 4 levels:
None: no bleeding on the posterior pharyngeal wall at the time of intubation and 10 minutes after intubation, and no bleeding from the nasal cavity after extubation.
Mild: bleeding on the posterior pharyngeal at intubation, no bleeding in the posterior wall of the pharynx 10 minutes after intubation, and no bleeding from the nasal cavity at extubation (bleeding occurs at only one of these times).
Moderate: bleeding on the posterior pharyngeal at the time intubation and 10 minutes after intubation, but no bleeding from the nasal cavity at extubation (bleeding occurs at two of these times).
Severe: bleeding on the posterior pharyngeal at the time intubation, 10 minutes after intubation, and bleeding from the nasal cavity at extubation (bleeding occurs at all three times).
Measured: 2 hour
Secondary outcomes (2)
Hemodynamic variables
This outcome reported : Systolic blood pressure (mmHg), diastolic blood pressure (mmHg), MAP (mmHg)
Measured: 2 hour
heart rate (bpm)
Hemodynamic variable
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Jan 2024
- Primary completion20 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral SurgeryStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iwan Fuadi, M.D., PhD, Principal investigator, Faculty of Medicine Universitas Padjadjaran Bandung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789549
- Sponsor's protocol ID
- AN-202501.01
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only resume of demographic and clinical characteristics, included age, height, weight, ASA physical status, gender, ETT size, duration of anesthesia, and duration of surgery, will be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Epinephrine Nasal Drops and Oxymetazoline Nasal Drops in Reducing Epistaxis During Nasal Intubation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06789549
- Acronym / sponsor ID
- AN-202501.01
- Conditions
- Oral Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 23 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.
Epistaxis is the most common complication of nasotracheal intubation. Incidence of epistaxis during nasotracheal intubation ranges from 22% to 80%. Epistaxis during nasotracheal intubation can lead to several complications such as nasal discomfort, airway obstruction, and blood aspiration. The most commonly used and available topical vasoconstrictor in drop form is oxymetazoline. However, oxymetazoline may not always be available in some hospitals, so epinephrine can be used as an alternative nasal decongestant to reduce the incidence of epistaxis during nasotracheal intubation.
Detailed description
Epistaxis associated with nasotracheal intubation can be from blood-tinged mucus to massive bleeding. Epistaxis during nasotracheal intubation can cause excessive force during the procedure, use of an endotracheal tube (ETT) larger than the nasal cavity, repeated intubation attempts, and abnormalities in the anatomy of the nose or nasopharynx. Epistaxis during nasotracheal intubation can lead to several complications such as nasal discomfort, airway obstruction, and blood aspiration.
Topical vasoconstrictors such as oxymetazoline are used to reduce the incidence and severity of epistaxis caused by nasotracheal intubation. Oxymetazoline nasal drops before nasotracheal intubation significantly increases the intranasal diameter and causes vasoconstriction of blood vessels, thereby reducing bleeding and damage to the nasal mucosa.
Epinephrine can be used as an alternative nasal decongestant to reduce the incidence of epistaxis during nasotracheal intubation. Administering 1 mL of 0.1% topical epinephrine reduces 25% nasal mucosal volume and decreases 37% blood flow, thereby providing nasal cavity expansion with lower hemodynamic and systemic effects.
Currently, there exists a lack of empirical research regarding the utilization of epinephrine drops for the prophylaxis of epistaxis in the context of nasotracheal intubation. Given this gap in the literature, the objective of this investigation is to conduct a comparative analysis between the application of 0.1% epinephrine nasal drops and 0.05% oxymetazoline nasal drops for the prevention of epistaxis during nasotracheal intubation procedures for oral surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epinephrine nasal drops | Experimental | Drug: epinephrine nasal dropstwenty patients was be administered randomly 1 mL of 0.1% epinephrine nasal drops. |
| oxymetazoline nasal drops | Active comparator | Drug: oxymetazoline nasal dropstwenty patients was be administered randomly receives 1 mL of 0.05% oxymetazoline nasal drops |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- underwent oral surgery with nasotracheal intubation
- aged 18-50 years
- ASA (American Society of Anesthesiologists) physical status of 1-2.
Key exclusion criteria (12 listed)
- allergy to the medications used
- nasal congestion, nasal polyps, allergic rhinitis
- hypertension and use of antihypertensive medications,
- abnormal coagulation factors, receiving antithrombotic and anticoagulant therapy,
- difficult intubation with a LEMON score ≥4,
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 |
|---|---|---|
| epinephrine nasal dropsAlso: Epinephrine 1mg/ml - Pt. Pharos TbkPatients in experimental arms received 1 mL of 0.1% epinephrine nasal drops before nasotracheal intubation | Drug | epinephrine nasal drops |
| oxymetazoline nasal dropsAlso: Oxymetazoline - Iliadin nasal drop 0,05%Patients in experimental arms received 1 mL of 0.1% oxymetazoline nasal drops before nasotracheal intubation | Drug | oxymetazoline nasal drops |
Primary outcome
Epistaxis
Time frame: 2 hour
The level of epistaxis was assessed during laryngoscopy intubation, 10 minutes after intubation using laryngoscopy, and immediately after extubation. The degree of epistaxis was graded on 4 levels: None: no bleeding on the posterior pharyngeal wall at the time of intubation and 10 minutes after intubation, and no bleeding from the nasal cavity after extubation. Mild: bleeding on the posterior pharyngeal at intubation, no bleeding in the posterior wall of the pharynx 10 minutes after intubation, and no bleeding from the nasal cavity at extubation (bleeding occurs at only one of these times). Moderate: bleeding on the posterior pharyngeal at the time intubation and 10 minutes after intubation, but no bleeding from the nasal cavity at extubation (bleeding occurs at two of these times). Severe: bleeding on the posterior pharyngeal at the time intubation, 10 minutes after intubation, and bleeding from the nasal cavity at extubation (bleeding occurs at all three times).
2 secondary outcomes
Hemodynamic variables
Time frame: 2 hour
heart rate (bpm)
Time frame: 2 hour
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 23 Jan 2025.
- Individual participant dataSharing planned: No. Only resume of demographic and clinical characteristics, included age, height, weight, ASA physical status, gender, ETT size, duration of anesthesia, and duration of surgery, will be shared
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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.
Iwan Fuadi, M.D., PhD principal investigator
Faculty of Medicine Universitas Padjadjaran Bandung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing epinephrine nasal drops and oxymetazoline nasal drops in people with Oral Surgery, run by Universitas Padjadjaran at 1 site in Indonesia.
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 12 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 23 Jan 2025. 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 Indonesia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Epistaxis (time frame: 2 hour). 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 23 Jan 2025.