Epinephrine Nebulization Prior to Nasotracheal Intubation

NCT05738564 | Completed Phase 3

• 1 other identifier: FMASU R 132/2021
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This randomised, prospective study performed in Ain shams university hospitals over 126 Patients ASA I and ASA II, trauma patients who suffered isolated mandibular fractures and necessitated nasal intubation during general anesthesia. The patients were randomly assigned to one of two equal groups: nasal Lidocaine drops followed by Oxymetazoline nasal drops group (OL) or Epinephrine mixed with Lidocaine as nebulization session (EL) group.

Conditions

Nasal Bleeding

Keywords

Nasotracheal intubation, nebulized epinephrine, epistaxis.

Outcome Measures

Primary Outcomes (1)

• estimate the degree of epistaxis

  Epistaxis degrees during intubation is classified to 4 degrees 1-No bleeding means No interference with the laryngoscopic view,2- minimal bleeding means Just blood-tinged ETT but no blood on the vocal cords or mouth floor, 3-moderate bleading means Blood on the vocal cords and mouth floor which Interferes with the laryngoscopic view, but is easy to confirm the laryngeal structure,4-severe bleeding means Blood on the vocal cords and mouth floor Hard to visualize the laryngeal structure without suction because of bleeding Nasal bleeding after intubation will be assessed by utilizing pharyngeal aspiration with a 14-F, 50-cm-long suction catheter linked to a 2.5-m-long suction tube at -100 mmHg pressure \[13\]. Based on the amount of blood sucked via the suction tube into the container, the severity of epistaxis was determined: none = no bleeding; mild = blood volume \< 50 cm; moderate = 50 cm \< blood volume \< 300 cm; severe = blood volume \> 300 cm

  the whole intraoperative time

Secondary Outcomes (2)

• intraoperative analgesia

  the whole intraoperative period

• intraoperative blood loss from surgical field

  the whole intraoperative period

Study Arms (2)

Group (EL) Epinepherine and Lidocaone group

ACTIVE COMPARATOR

Group (EL) (63 patients) received a session of nebulization in the pre-induction area, consisting of 1 ml epinephrine (1:1000 Martindale Pharma, an Ethypharm Group Company, ampoule 1 mg added to 9 ml of normal saline, then 1 ml of that put in nebulization cup + 2 ml lidocaine 2%), nebulized prior to the induction of anesthesia.(63 patients) received a session of nebulization in the pre-induction area, consisting of 1 ml epinephrine (1:1000 Martindale Pharma, an Ethypharm Group Company, ampoule 1 mg added to 9 ml of normal saline, then 1 ml of that put in nebulization cup + 2 ml lidocaine 2%), nebulized prior to the induction of anesthesia.

Drug: Epinephrine Inhalation Solution

Group( OL) Oxymetazoline and lidocaine group

ACTIVE COMPARATOR

Group OL (63 patients): These patients received five drops of lidocaine hydrochloride (Xylocaine 2%, 20 mg/ml; AstraZeneca, London, UK) using a prefilled dropper, followed by six drops of hydrochloride Oxymetazoline (Otrivin adult nasal drops 0.1%, 10 ml of 1 mg/ml; Novartis Consumer Health, UK Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK) in each nostril in the pre-induction room just before the induction of anesthesia

Drug: Epinephrine Inhalation Solution

Interventions

Epinephrine Inhalation Solution DRUG

epinephrine prepared solution mixed with lidocaine (EL) Otrivin adult nasal drops 0.1Otrivin adult nasal drops 0.1%, 10 ml of 1 mg/ml; Novartis Consumer Health, UK Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK) in each nostril in the pre-induction room just before the induction of anesthesia

Also known as: oxymetazoline lidocaine

Group (EL) Epinepherine and Lidocaone group; Group( OL) Oxymetazoline and lidocaine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cases with American Society of Anesthesiologists (ASA) classes I and II.
• Patients scheduled for elective oral isolated mandibular fracture fixation requiring nasotracheal intubation.

You may not qualify if:

• Nasal abnormality history (such as polyp , surgery or nasal trauma).
• Frequent epistaxis history.
• Patients suffering valvular heart disease, hypertension, ischemic heart disease or arrhythmias.
• Patients using drugs (anticoagulation therapy, non-steroidal anti-inflammatory drugs, and oral decongestants).
• Patients receiving medications known to alter the parameters under investigation including β-blockers, calcium channel blockers, or vasodilators.
• Patients known to have hypersensitivity to medications used in this study.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, 3567, Egypt

Location

Related Publications (1)

• Song J. A comparison of the effects of epinephrine and xylometazoline in decreasing nasal bleeding during nasotracheal intubation. J Dent Anesth Pain Med. 2017 Dec;17(4):281-287. doi: 10.17245/jdapm.2017.17.4.281. Epub 2017 Dec 28.

  PMID: 29349350 BACKGROUND

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Mohammed Shorbagy, MD

  Assisstant professor of anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, prospective trial performed on 2 equal groups

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 22, 2023
• Study Start: September 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: September 30, 2022
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: after 1 month will be available for 6 months
• Access Criteria: through the official email sabah\ nageeb@med.asu.edu.eg

Locations

EG (1)