Clinical trial NCT05738564: Epinephrine Nebulization Prior to Nasotracheal Intubation
Official title: Pre-emptive Epinephrine Nebulization Prior to Nasotracheal Intubation for Mandibular Fracture Fixation Surgeries:Dose it Really Differs? a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasal Bleeding
Keywords: Nasotracheal intubation, nebulized epinephrine, epistaxis.
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, prospective trial performed on 2 equal groups
Primary purpose: PREVENTION

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.

Detailed 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

Eligibility criteria: 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 β-blockers, calcium channel blockers, or vasodilators.
* Patients known to have hypersensitivity to medications used in this study.

Primary outcomes:
measure: estimate the degree of epistaxis
timeFrame: the whole intraoperative time
Secondary outcomes:
measure: intraoperative analgesia
timeFrame: the whole intraoperative period
measure: intraoperative blood loss from surgical field
timeFrame: the whole intraoperative period
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
Study officials:
affiliation: Assisstant professor of anesthesia
name: Mohammed Shorbagy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.