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NCT Number: NCT06801522

Adrenaline Nasal Pack vs Xylometazoline Nasal Drops 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.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shaheed Mohtarma Benazir Bhutto Institute of Trauma

Karachi, Sindh, Pakistan

Location status: Recruiting

Location contact

Iqra Ashraf, MBBS, FCPS TRAINEE

PRINCIPAL_INVESTIGATOR

Sidra Tahir, MBBS, FCPS TRAINEE

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Nasal bleeding

    Time frame: At the time of Intubation and Extubation

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+923346441539

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

CONTACT

[email protected]

+92333 2474831

Sponsors and collaborators

Lead sponsor

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2025
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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