Epinephrine Nasal Drops for Epistaxis During Nasal Intubation

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.

Study Overview

• Status: Completed
• Conditions: Oral Surgery
• Intervention / Treatment: Drug: epinephrine nasal drops; Drug: oxymetazoline nasal drops

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Indonesia
  • West Java
    • Bandung, West Java, Indonesia, 40161
      • Hasan Sadikin General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: epinephrine nasal drops; twenty patients was be administered randomly 1 mL of 0.1% epinephrine nasal drops.	Drug: epinephrine nasal drops; Patients in experimental arms received 1 mL of 0.1% epinephrine nasal drops before nasotracheal intubation; Other Names: Epinephrine 1mg/ml - Pt. Pharos Tbk
Active Comparator: oxymetazoline nasal drops; twenty patients was be administered randomly receives 1 mL of 0.05% oxymetazoline nasal drops	Drug: oxymetazoline nasal drops; Patients in experimental arms received 1 mL of 0.1% oxymetazoline nasal drops before nasotracheal intubation; Other Names: Oxymetazoline - Iliadin nasal drop 0,05%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic variables	This outcome reported : Systolic blood pressure (mmHg), diastolic blood pressure (mmHg), MAP (mmHg)	2 hour
heart rate (bpm)	Hemodynamic variable	2 hour

Collaborators and Investigators

• Sponsor: Universitas Padjadjaran
• Investigators: Principal Investigator: Iwan Fuadi, M.D., PhD, Faculty of Medicine Universitas Padjadjaran Bandung

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): March 20, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Hemorrhage; Nose Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Epistaxis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Cardiotonic Agents; Bronchodilator Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Epinephrine; Oxymetazoline; Racepinephrine; Epinephryl borate; Phenylephrine
• Other Study ID Numbers: AN-202501.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No