Adrenaline Nasal Pack vs Xylometazoline Nasal Drops During Nasotracheal Intubation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nasal Bleeding Nasotracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group Xylometazoline will receive xylometazoline nasal drops and Group Adrenaline will receive adrenaline nasal pack

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

This study is single blind, assessor is kept blind because participants are difficult to mask due to well distinguished treatment plan.

Study Groups

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Xylometazoline Group

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

Group Type EXPERIMENTAL

0.1% xylometazoline nasal drops

Intervention Type DRUG

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

Adrenaline Group

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

Group Type ACTIVE_COMPARATOR

Adrenaline nasal pack

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No