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IRCT20221226056933N1 IRCT 2023-02-10 Ain Shams University Pre-emptive Epinephrine Nebulization Prior to Nasotracheal Intubation for Mandibular Fracture Fixation Surgeries: Dose it Really Differs? a Randomized Controlled Study Pre-emptive Epinephrine Nebulization Prior to Nasotracheal Intubation for Mandibular Fracture Fixation Surgeries 2021-09-01 anticipated 126 Complete https://irct.ir/trial/68493 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization was performed using a computer-generated randomization sequence and allocation concealment to be maintained all through the time of procedure, by using opaque, numbered, and sealed envelopes, Blinding description: The investigators are aware of the given medication, Only the anesthesiologist who performed the nasal intubation was not aware of the given medication. 3 Nasal Bleeding - mandibular fracture fixation surgeries. Intervention 1: Intervention group: Active Comparator: Group (EL) Epinepherine and Lidocaone groupGroup (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. Intervention 2: Intervention group: Oxymetazoline and lidocaine groupGroup OL (63 patients): These patients received five drops of lidocaine hydrochloride (Xylocaine 2%, 20 mg/ml;Active Comparator: Group( OL) Oxymetazoline and lidocaine groupGroup 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. Yes - There is a plan to make this available What will be shared: Pre-emptive Epinephrine Nebulization Prior to Nasotracheal Intubation for Mandibular Fracture Fixation Surgeries:Dose it Really Differs? a Randomized Controlled Study When: after 6 months for 1 year To whom: For people working in anesthesia field Conditions: as citation Where to obtain: sabah.nageeb@yahoo.com How to obtain: through the official email within one week , can share data Comments:
public Sabah Naguib Barsoom Ayoub
131- Ramsis street
Abbasia- Cairo-Egypt Egypt 7539 +20 2 26857539 FMASU@med.asu.edu.eg Ain Shams University scientific Mohammed Sayed Shorbagy
131- Ramsis street
Abbasia- Cairo-Egypt Egypt 7539 +20 2 26857539 mohammed.s.shorbagy@med.asu.edu.eg Ain Shams University Egypt • Cases with American Society of Anesthesiologists (ASA) classes I and II. • Patients scheduled for elective oral isolated mandibular fracture fixation requiring nasotracheal intubation. 18 years no limit Both • 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 decongestant • 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. R04.0 Epistaxis Prevention Prevention Intervention group: Active Comparator: Group (EL) Epinepherine and Lidocaone groupGroup (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. Intervention group: Oxymetazoline and lidocaine groupGroup OL (63 patients): These patients received five drops of lidocaine hydrochloride (Xylocaine 2%, 20 mg/ml;Active Comparator: Group( OL) Oxymetazoline and lidocaine groupGroup 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 Estimate the degree of epistaxis during nasal intubation. Timepoint: after the intervention. Method of measurement: 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. 1. intraoperative analgesia. Timepoint: whole intraoperative time. Method of measurement: intraoperative analgesia is indicated by intraoperative hemodynamics and total intraoperative fentanyl consumption. 2. intraoperative blood loss from surgical field. Timepoint: intraoperative time. Method of measurement: intraoperative volume of blood loss was estimated. Ain Shams University Approved 2064-01-06 RESEARCH ETHICS COMMITTEE ( REC) Board Affiliation: Ain Shams University !31- Ramsis street Abbasia- Cairo-Egypt Cairo Egypt