Epinephrine Nebulization Prior to Nasotracheal Intubation

Nasal Bleeding Clinical Trial

Official title:

Pre-emptive Epinephrine Nebulization Prior to Nasotracheal Intubation for Mandibular Fracture Fixation Surgeries:Dose it Really Differs? a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05738564
• Other study ID #: FMASU R 132/2021
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: February 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

One group received epinephrine mixed with lidocaine as nebulization session (EL group) and the other group received nasal lidocaine drops followed by Oxymetazoline nasal drops group (OL). Before the preparation of the airway, we examined the nasal cavity by using a light source to select the target nostril; if we could not determine, we chose the right nostril. No premedication was administered. 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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 ß-blockers, calcium channel blockers, or vasodilators.
• Patients known to have hypersensitivity to medications used in this study.

Related Conditions & MeSH terms

• Epistaxis
• Nasal Bleeding

Intervention

Drug:
• Epinephrine Inhalation Solution
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

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	intraoperative analgesia	intraoperative analgesia is indicated by intraoperative hemodynamics and total intraoperative fentanyl consumption	the whole intraoperative period
Secondary	intraoperative blood loss from surgical field	itraoperative volume of blood loss was estimated	the whole intraoperative period