Adrenaline Nasal Pack vs Xylometazoline Nasal Drops During Nasotracheal Intubation

Официальное название

Comparison of the Efficacy of Adrenaline Nasal Pack and Xylometazoline Nasal Drops in Decreasing Nasal Bleeding During Nasotracheal Intubation

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 0.1% xylometazoline nasal drops
  Xylometazoline is direct acting, non selective, adrenergic agonist binding with alpha 1\&2 receptors, used for vasoconstriction to decrease nasal bleeding.
• Препарат Adrenaline nasal pack
  Adrenaline is direct acting, non selective, adrenergic agonist binding with alpha and beta receptors both, used for vasoconstriction to decrease nasal bleeding.

Первичные конечные точки

• Nasal bleeding [Срок оценки: At the time of Intubation and Extubation]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Пакистан · 1 центр

• Shaheed Mohtarma Benazir Bhutto Institute of Trauma — Karachi

Публикации

• Sato-Boku A, Sento Y, Kamimura Y, Kako E, Okuda M, Tachi N, Okumura Y, Hashimoto M, Hoshijima H, Suzuki F, Sobue K. Comparison of hemostatic effect and safety between epinephrine and tramazoline during nasotracheal intubation: a double-blind randomized trial. BMC Anesthesiol. 2021 Sep 30;21(1):235. doi: 10.1186/s12871-021-01454-y. PMID 34592949
• Ozkan ASM, Akbas S, Toy E, Durmus M. North Polar Tube Reduces the Risk of Epistaxis during Nasotracheal Intubation: A prospective, Randomized Clinical Trial. Curr Ther Res Clin Exp. 2018 Oct 9;90:21-26. doi: 10.1016/j.curtheres.2018.09.002. eCollection 2019. PMID 30787962
• Earle R, Shanahan E, Vaghadia H, Sawka A, Tang R. Epistaxis 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. Can J Anaesth. 2017 Apr;64(4):370-375. doi: 10.1007/s12630-017-0813-4. Epub 2017 Jan 11. PMID 28078544
• 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. PMID 29349350
• 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. PMID 32934988

Идентификаторы

NCT: NCT06801522 · ERC-000104/SMBBIT/2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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