Nasal Bleeding Clinical Trial
Official title:
Pre-emptive Epinephrine Nebulization Prior to Nasotracheal Intubation for Mandibular Fracture Fixation Surgeries:Dose it Really Differs? a Randomized Controlled Study
Verified date | February 2023 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 126 |
Est. completion date | September 30, 2022 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 ß-blockers, calcium channel blockers, or vasodilators. - Patients known to have hypersensitivity to medications used in this study. |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University Hospital | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | the whole intraoperative time | |
Secondary | intraoperative analgesia | intraoperative analgesia is indicated by intraoperative hemodynamics and total intraoperative fentanyl consumption | the whole intraoperative period | |
Secondary | intraoperative blood loss from surgical field | itraoperative volume of blood loss was estimated | the whole intraoperative period |
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