Epinephrine Nebulization Prior to Nasotracheal Intubation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group (EL) Epinepherine and Lidocaone group 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
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:
|
| Active Comparator: Group( OL) Oxymetazoline and lidocaine group 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
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:
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Outcome Measures
Primary Outcome Measures
- estimate the degree of epistaxis [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 Outcome Measures
- intraoperative analgesia [the whole intraoperative period]
intraoperative analgesia is indicated by intraoperative hemodynamics and total intraoperative fentanyl consumption
- intraoperative blood loss from surgical field [the whole intraoperative period]
itraoperative volume of blood loss was estimated
Eligibility Criteria
Criteria
Inclusion Criteria:
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Cases with American Society of Anesthesiologists (ASA) classes I and II.
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Patients scheduled for elective oral isolated mandibular fracture fixation requiring nasotracheal intubation.
Exclusion Criteria:
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Nasal abnormality history (such as polyp , surgery or nasal trauma).
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Frequent epistaxis history.
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Patients suffering valvular heart disease, hypertension, ischemic heart disease or arrhythmias.
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Patients using drugs (anticoagulation therapy, non-steroidal anti-inflammatory drugs, and oral decongestants).
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Patients receiving medications known to alter the parameters under investigation including β-blockers, calcium channel blockers, or vasodilators.
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Patients known to have hypersensitivity to medications used in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ain Shams University Hospital | Cairo | Egypt | 3567 |
Sponsors and Collaborators
- Ain Shams University
Investigators
- Principal Investigator: Mohammed Shorbagy, MD, Assisstant professor of anesthesia
Study Documents (Full-Text)
None provided.More Information
Publications
- FMASU R 132/2021