Adrenaline Nasal Pack vs Xylometazoline Nasal Drops During Nasotracheal Intubation

NCT06801522 | Recruiting Phase 2

• 1 other identifier: ERC-000104/SMBBIT/2023
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Bleeding; Nasotracheal Intubation

Keywords

Nasal bleeding, Nasotracheal intubation, adrenaline pack, xylometazoline nasal drops

Outcome Measures

Primary Outcomes (1)

• Nasal bleeding

  At the time of Intubation and Extubation

Study Arms (2)

Xylometazoline Group

EXPERIMENTAL

Participants in this group will receive xylometazoline nasal drops before nasotracheal intubation

Drug: 0.1% xylometazoline nasal drops

Adrenaline Group

ACTIVE COMPARATOR

Participants in this group will recieve adrenaline nasal packing before nasotracheal intubation

Drug: Adrenaline nasal pack

Interventions

0.1% xylometazoline nasal drops DRUG

Xylometazoline is direct acting, non selective, adrenergic agonist binding with alpha 1\&2 receptors, used for vasoconstriction to decrease nasal bleeding.

Xylometazoline Group

Adrenaline nasal pack DRUG

Adrenaline is direct acting, non selective, adrenergic agonist binding with alpha and beta receptors both, used for vasoconstriction to decrease nasal bleeding.

Adrenaline Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaheed Mohtarma Benazir Bhutto Institue of Trauma: lead

Study Sites (1)

Shaheed Mohtarma Benazir Bhutto Institute of Trauma

Karachi, Sindh, Pakistan

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Dr Sidra Javed Consultant Anaesthetist, MBBS, FCPS, PAIN FELLOW

CONTACT

+92333 2474831; sidra_dow@yahoo.com

Dr Mirza Shahzad Baig Consultant Anaesthetist, MBBS, MCPS, FCPS

CONTACT

+923346441539; drshahzadbaig@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study is single blind, assessor is kept blind because participants are difficult to mask due to well distinguished treatment plan.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Group Xylometazoline will receive xylometazoline nasal drops and Group Adrenaline will receive adrenaline nasal pack

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: December 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 30, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)