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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221226056933N1
Enrollment
126
Registered
2023-02-10
Start date
2021-09-01
Completion date
Unknown
Last updated
2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Bleeding - mandibular fracture fixation surgeries. Epistaxis

Interventions

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
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.

Sponsors

Ain Shams University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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

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 decongestant • 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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Egypt

Contacts

Public ContactSabah Naguib Barsoom Ayoub

Ain Shams University

FMASU@med.asu.edu.eg+20 2 26857539

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026