Clinical trial NCT06801522: Adrenaline Nasal Pack vs Xylometazoline Nasal Drops During Nasotracheal Intubation
Official title: Comparison of the Efficacy of Adrenaline Nasal Pack and Xylometazoline Nasal Drops in Decreasing Nasal Bleeding During Nasotracheal Intubation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Nasal Bleeding
Nasotracheal Intubation
Keywords: Nasal bleeding, Nasotracheal intubation, adrenaline pack, xylometazoline nasal drops
Lead sponsor: Shaheed Mohtarma Benazir Bhutto Institue of Trauma
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group Xylometazoline will receive xylometazoline nasal drops and Group Adrenaline will receive adrenaline nasal pack
Primary purpose: PREVENTION

Brief summary: The goal of this trial is to compare efficacy of xylometazoline nasal drops and adrenaline nasal pack in participants undergoing elective oromaxillofacial surgeries.

The main question aim to answer is xylometazoline nasal drops better than adrenaline nasal packing in terms of nasal bleeding during nasotracheal intubation. Researchers are comparing 2 groups of participants.

Participants in group Xylometazoline are receiving 0.1% xylometaxoline nasal drops.

Participants in group Adrenaline are receiving adrenaline nasal packing.

Detailed description: This study is conducting after permission from institutional ethical committee. Participants came for elective OMF surgery under general anesthesia are enrolled in this study who fulfilled the inclusion criteria. Informed consent is taken from the participants. Brief history about demographic data was taken from each participant. All participants are examined for airway assessment, cardiovascular and respiratory examination before undergoing anesthesia. Participants are divided into 2 groups by simple lottery method in group xylometazoline and group adrenaline.

Group Xylometazoline: receive 3 to 5 drops of 0.1% xylometazoline nasal drops in selected nostril 15 mins before transfer to OT.

Group Adrenaline: receive intranasal packing with adrenaline soaked gauze piece in selected nostril. Packing is done 15 mins before transfer to OT and removed after 7 to 10 minutes. Proper monitoring of vital signs will be done in preoperative area.

Anesthesia machine and accessories are checked, and drugs including emergency drugs are kept ready. Baseline BP, heart rate, ECG, and peripheral oxygen saturation is obtained and recorded from multipara monitor. All participants are preoxygenated by 100% oxygen for 5 mins. Induction is done with propofol (1%) 2mg/kg and atracurium 0.5 mg/kg by senior anesthesiologist present. The anesthetist present in OT is blind to both groups. Laryngoscopy is done by an experienced anesthesiologist using a MAC 3 or 4 blade based on participants' anatomy. Nasotracheal intubation is done by a cuffed lubricated (with lidocaine 2%) nasal tube of appropriate size. Anesthesia is maintained with atracurium 0.1 mg/kg and isoflurane in 60% O2 at 3L flow.

The anesthesiologist will record incidence and severity of bleeding at the time of intubation and extubation.

Data will be analyzed on SPSS version 20. Chi square test will be used to compare the incidence of nasal bleeding in both groups. Effect modifiers are controlled through stratification of age, gender, diabetes mellitus, hypertension to see the effect of these on the outcome variables. Post stratification chi square test will be applied taking P-value of \<0.05 as statistically significant.

Eligibility criteria: Inclusion Criteria:

* ASA 1 and 2
* Age group between 18-60 years
* Mallampati score 1 and 2
* Either gender
* Participants who undergo elective oromaxillofacial surgery

Exclusion Criteria:

* Lack of consent
* Participants with anticipated difficult airway
* Participants receiving anticoagulant therapy
* History of nasal abnormality (nasal surgery, trauma, polyp, obstruction)
* History of repeated epistaxis
* History of uncontrolled hypertension, diabetes, pregnancy, and any other cardiac or cerebral events.

Primary outcomes:
measure: Nasal bleeding
timeFrame: At the time of Intubation and Extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Shaheed Mohtarma Benazir Bhutto Institute of Trauma
state: Sindh
Study officials:
References:
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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.
citation: Patel S, Hazarika A, Agrawal P, Jain D, Panda NK. A prospective randomized trial of xylometazoline drops and epinephrine merocele nasal pack for reducing epistaxis during nasotracheal intubation. J Dent Anesth Pain Med. 2020 Aug;20(4):223-231. doi: 10.17245/jdapm.2020.20.4.223. Epub 2020 Aug 27.