Adrenaline Nasal Pack Vs Xylometazoline Nasal Drops During Nasotracheal Intubation

January 24, 2025 updated by: IQRA ASHRAF, Shaheed Mohtarma Benazir Bhutto Institue of Trauma

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr Sidra Javed Consultant Anaesthetist, MBBS, FCPS, PAIN FELLOW
  • Phone Number: +92333 2474831
  • Email: sidra_dow@yahoo.com

Study Contact Backup

  • Name: Dr Mirza Shahzad Baig Consultant Anaesthetist, MBBS, MCPS, FCPS
  • Phone Number: +923346441539
  • Email: drshahzadbaig@hotmail.com

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Recruiting
        • Shaheed Mohtarma Benazir Bhutto Institute of Trauma
        • Contact:
          • Iqra Ashraf, MBBS, FCPS TRAINEE
        • Contact:
          • Sidra Tahir, MBBS, FCPS TRAINEE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Xylometazoline Group
Participants in this group will receive xylometazoline nasal drops before nasotracheal intubation
Drug: 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.
Active Comparator: Adrenaline Group
Participants in this group will recieve adrenaline nasal packing before nasotracheal intubation
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nasal bleeding
Time Frame: At the time of Intubation and Extubation
At the time of Intubation and Extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 24, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERC-000104/SMBBIT/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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