Epinephrine Nasal Drops for Epistaxis During Nasal Intubation

NCT06789549 | Completed Phase 2 DMC

• 1 other identifier: AN-202501.01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Hemodynamic variables

  2 hour

• heart rate (bpm)

  2 hour

Study Arms (2)

epinephrine nasal drops

EXPERIMENTAL

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

Drug: epinephrine nasal drops

oxymetazoline nasal drops

ACTIVE COMPARATOR

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

Drug: oxymetazoline nasal drops

Interventions

epinephrine nasal drops DRUG

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

Also known as: Epinephrine 1mg/ml - Pt. Pharos Tbk

epinephrine nasal drops

oxymetazoline nasal drops DRUG

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

Also known as: Oxymetazoline - Iliadin nasal drop 0,05%

oxymetazoline nasal drops

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Interventions

Epinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Iwan Fuadi, M.D., PhD

  Faculty of Medicine Universitas Padjadjaran Bandung

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 23, 2025
• Study Start: January 1, 2024
• Primary Completion: March 20, 2024
• Study Completion: April 1, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)