Epinephrine Nasal Drops for Epistaxis During Nasal Intubation

NCT ID: NCT06789549

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-04-01

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.

Conditions

Oral Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

epinephrine nasal drops

twenty patients was be administered randomly 1 mL of 0.1% epinephrine nasal drops.

Group Type: EXPERIMENTAL

epinephrine nasal drops

Intervention Type: DRUG

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

oxymetazoline nasal drops

twenty patients was be administered randomly receives 1 mL of 0.05% oxymetazoline nasal drops

Group Type: ACTIVE_COMPARATOR

oxymetazoline nasal drops

Intervention Type: DRUG

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

Interventions

epinephrine nasal drops

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

Intervention Type: DRUG

oxymetazoline nasal drops

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

Intervention Type: DRUG

Other Intervention Names

Epinephrine 1mg/ml - Pt. Pharos Tbk; Oxymetazoline - Iliadin nasal drop 0,05%

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitas Padjadjaran

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iwan Fuadi, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Universitas Padjadjaran Bandung

Locations

Hasan Sadikin General Hospital

Bandung, West Java, Indonesia

Countries

Indonesia

Other Identifiers

AN-202501.01

Identifier Type: -

Identifier Source: org_study_id