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Epinephrine Nebulization Prior to Nasotracheal Intubation

Primary Purpose

Nasal Bleeding

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Epinephrine Inhalation Solution
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nasal Bleeding focused on measuring Nasotracheal intubation, nebulized epinephrine, epistaxis.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ain Shams University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group (EL) Epinepherine and Lidocaone group

Group( OL) Oxymetazoline and lidocaine group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

estimate the degree of epistaxis
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
intraoperative analgesia is indicated by intraoperative hemodynamics and total intraoperative fentanyl consumption
intraoperative blood loss from surgical field
itraoperative volume of blood loss was estimated

Full Information

First Posted
January 11, 2023
Last Updated
February 12, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05738564
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Bleeding
Keywords
Nasotracheal intubation, nebulized epinephrine, epistaxis.

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomised, prospective trial performed on 2 equal groups
Masking
Care Provider
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group (EL) Epinepherine and Lidocaone group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group( OL) Oxymetazoline and lidocaine group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Epinephrine Inhalation Solution
Other Intervention Name(s)
oxymetazoline lidocaine
Intervention Description
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
Primary Outcome Measure Information:
Title
estimate the degree of epistaxis
Description
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
Time Frame
the whole intraoperative time
Secondary Outcome Measure Information:
Title
intraoperative analgesia
Description
intraoperative analgesia is indicated by intraoperative hemodynamics and total intraoperative fentanyl consumption
Time Frame
the whole intraoperative period
Title
intraoperative blood loss from surgical field
Description
itraoperative volume of blood loss was estimated
Time Frame
the whole intraoperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Shorbagy, MD
Organizational Affiliation
Assisstant professor of anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Hospital
City
Cairo
ZIP/Postal Code
3567
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
through the official email
IPD Sharing Time Frame
after 1 month will be available for 6 months
IPD Sharing Access Criteria
through the official email sabah_nageeb@med.asu.edu.eg
Citations:
PubMed Identifier
29349350
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.
Results Reference
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Epinephrine Nebulization Prior to Nasotracheal Intubation

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