Epinephrine Nasal Drops for Epistaxis During Nasal Intubation

Phase 2

Completed

• Conditions: Oral Surgery
• Interventions: Drug: epinephrine nasal drops; Drug: oxymetazoline nasal drops

• Registration Number: NCT06789549
• Lead Sponsor: Universitas Padjadjaran

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.

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-03-20
• Study Completion: 2024-04-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Study First Posted: 2025-01-23
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
epinephrine nasal drops	epinephrine nasal drops	twenty patients was be administered randomly 1 mL of 0.1% epinephrine nasal drops.
oxymetazoline nasal drops	oxymetazoline nasal drops	twenty patients was be administered randomly receives 1 mL of 0.05% oxymetazoline nasal drops

Primary Outcome Measures

Name	Time	Method
Epistaxis	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).

Secondary Outcome Measures

Name	Time	Method
Hemodynamic variables	2 hour	This outcome reported : Systolic blood pressure (mmHg), diastolic blood pressure (mmHg), MAP (mmHg)
heart rate (bpm)	2 hour	Hemodynamic variable

Trial Locations

Locations (1)

Hasan Sadikin General Hospital; 🇮🇩 Bandung, West Java, Indonesia