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Completed

NCT Number: NCT05738564

Epinephrine Nebulization Prior to Nasotracheal Intubation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ain Shams University Hospital

Cairo, 3567, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: oxymetazoline lidocaine

Primary outcomes

  1. estimate the degree of epistaxis

    Time frame: the whole intraoperative time

    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

Secondary outcomes

  1. intraoperative analgesia

    Time frame: the whole intraoperative period

    intraoperative analgesia is indicated by intraoperative hemodynamics and total intraoperative fentanyl consumption

  2. intraoperative blood loss from surgical field

    Time frame: the whole intraoperative period

    itraoperative volume of blood loss was estimated

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 22, 2023
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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