Clinical trial NCT06789549: Epinephrine Nasal Drops for Epistaxis During Nasal Intubation
Official title: Comparing the Efficacy of Epinephrine Nasal Drops and Oxymetazoline Nasal Drops in Reducing Epistaxis During Nasal Intubation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Surgery
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria: patients

* underwent oral surgery with nasotracheal intubation
* aged 18-50 years
* ASA (American Society of Anesthesiologists) physical status of 1-2.

Exclusion Criteria:

* 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,
* 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

Primary outcomes:
measure: Epistaxis
timeFrame: 2 hour
Secondary outcomes:
measure: Hemodynamic variables
timeFrame: 2 hour
measure: heart rate (bpm)
timeFrame: 2 hour
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Hasan Sadikin General Hospital
state: West Java
Study officials:
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Iwan Fuadi, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: