A Phase 2/3 interventional study of 0.1% xylometazoline nasal drops and Adrenaline nasal pack in Nasal Bleeding and Nasotracheal Intubation, sponsored by Shaheed Mohtarma Benazir Bhutto Institue of Trauma. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Shaheed Mohtarma Benazir Bhutto Institue of Trauma · Phase 2/3, Interventional, and Prevention
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.
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.
96 studies on the registry are indexed under Epistaxis; 22 are open to participants now.
This study's planned enrollment of 70 is close to the median of 64 across 81 interventional studies indexed under Epistaxis.
Browse Epistaxis studies →Shaheed Mohtarma Benazir Bhutto Institue of Trauma is the lead sponsor of 12 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Participants in this group will receive xylometazoline nasal drops before nasotracheal intubation
Drug: 0.1% xylometazoline nasal drops
Participants in this group will recieve adrenaline nasal packing before nasotracheal intubation
Drug: Adrenaline nasal pack
Xylometazoline is direct acting, non selective, adrenergic agonist binding with alpha 1\&2 receptors, used for vasoconstriction to decrease nasal bleeding.
Adrenaline is direct acting, non selective, adrenergic agonist binding with alpha and beta receptors both, used for vasoconstriction to decrease nasal bleeding.
Nasal bleeding
Time frame: At the time of Intubation and Extubation
Plan to share: No — Patient Confidentialit: Sharing IPD could compromise patient confidentiality and anonymity. Informed consent: Participants are not providing informed consent for their data to be shared and it could raise ethical concerns.
Started Dec 2024 (actual). Primary completion is estimated for Mar 2025, 3 months after the start.
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Shaheed Mohtarma Benazir Bhutto Institue of Trauma