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NCT Number: NCT06789549

Epinephrine Nasal Drops for Epistaxis During Nasal Intubation

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.

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Key information

Conditions

Oral Surgery

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epinephrine nasal drops

Drug

Patients in experimental arms received 1 mL of 0.1% epinephrine nasal drops before nasotracheal intubation

Other names: Epinephrine 1mg/ml - Pt. Pharos Tbk

oxymetazoline nasal drops

Drug

Patients in experimental arms received 1 mL of 0.1% oxymetazoline nasal drops before nasotracheal intubation

Other names: Oxymetazoline - Iliadin nasal drop 0,05%

Primary outcomes

  1. 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).

Secondary outcomes

  1. Hemodynamic variables

    Time frame: 2 hour

    This outcome reported : Systolic blood pressure (mmHg), diastolic blood pressure (mmHg), MAP (mmHg)

  2. heart rate (bpm)

    Time frame: 2 hour

    Hemodynamic variable

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study title

Comparing the Efficacy of Epinephrine Nasal Drops and Oxymetazoline Nasal Drops in Reducing Epistaxis During Nasal Intubation: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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