Comparison of hemostatic effect and safety between epinephrine and tramazoline during nasotracheal intubation: a double-blind randomized trial.
Aiji Sato-Boku, Yoshiki Sento, Yuji Kamimura...
https://pubmed.ncbi.nlm.nih.gov/34592949Actively Recruiting
Phase 2
Phase 3
Age: 18Years - 60Years
All Genders
ID06801522
Comparison of the Efficacy of Adrenaline Nasal Pack and Xylometazoline Nasal Drops in Decreasing Nasal Bleeding During Nasotracheal Intubation
Led by Shaheed Mohtarma Benazir Bhutto Institue of Trauma · Updated on 2025-01-30
70
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the effects of xylometazoline nasal drops and adrenaline nasal packing on nasal bleeding during nasotracheal intubation in participants undergoing elective oromaxillofacial surgeries. The trial aims to determine which of these two treatments better reduces nasal bleeding during the procedure. This study includes participants aged 18 to 60 years with specific health criteria to ensure safety and accuracy. Participants are randomly assigned to one of two groups. One group receives 0.1% xylometazoline nasal drops, administered as 3 to 5 drops in the selected nostril 15 minutes before surgery. The other group receives adrenaline nasal packing, where a gauze soaked in adrenaline is placed inside the nostril 15 minutes before surgery and removed after 7 to 10 minutes. Both groups undergo nasotracheal intubation under general anesthesia with careful monitoring. Throughout the study, participants will have vital signs monitored, including blood pressure, heart rate, ECG, and oxygen saturation. An experienced anesthesiologist will perform the procedures and record the incidence and severity of nasal bleeding during intubation and extubation. Data will be analyzed to compare bleeding outcomes between groups while considering factors like age, gender, and medical history. Participation lasts through the surgical procedure and immediate recovery monitoring.
CONDITIONS
Brief Title
Adrenaline Nasal Pack vs Xylometazoline Nasal Drops During Nasotracheal Intubation
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- ASA physical status 1 and 2
- Age between 18 and 60 years
- Mallampati score 1 or 2
- Any gender
- Scheduled for elective oromaxillofacial surgery
You will not qualify if you...
- Lack of consent
- Anticipated difficult airway
- Receiving anticoagulant therapy
- History of nasal surgery, trauma, polyp, or obstruction
- History of repeated nosebleeds
- Uncontrolled hypertension, diabetes, pregnancy, or cardiac or cerebral events history
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single day on surgery day
Participants receive either xylometazoline nasal drops or adrenaline nasal packing before nasotracheal intubation during elective oromaxillofacial surgery under general anesthesia.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Shaheed Mohtarma Benazir Bhutto Institute of Trauma
Karachi, Sindh, Pakistan
Actively Recruiting
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Research Team
D
Dr Sidra Javed Consultant Anaesthetist, MBBS, FCPS, PAIN FELLOW
D
Dr Mirza Shahzad Baig Consultant Anaesthetist, MBBS, MCPS, FCPS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
North Polar Tube Reduces the Risk of Epistaxis during Nasotracheal Intubation: A prospective, Randomized Clinical Trial.
Ahmet Seli M Özkan, Sedat Akbas, Erol Toy...
https://pubmed.ncbi.nlm.nih.gov/30787962Epistaxis during nasotracheal intubation: a randomized trial of the Parker Flex-Tip™ nasal endotracheal tube with a posterior facing bevel versus a standard nasal RAE endotracheal tube.
Rosie Earle, Enda Shanahan, Himat Vaghadia...
https://pubmed.ncbi.nlm.nih.gov/28078544A comparison of the effects of epinephrine and xylometazoline in decreasing nasal bleeding during nasotracheal intubation.
Jaegyok Song
https://pubmed.ncbi.nlm.nih.gov/29349350A prospective randomized trial of xylometazoline drops and epinephrine merocele nasal pack for reducing epistaxis during nasotracheal intubation.
Sonam Patel, Amarjyoti Hazarika, Prachi Agrawal...
https://pubmed.ncbi.nlm.nih.gov/32934988