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Minimising nasal bleeding by application of decongestant drops before putting tube through nostrils

Completed
Conditions
Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,
Registration Number
CTRI/2019/04/018616
Lead Sponsor
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Brief Summary

Nasotracheal intubation is a specialized procedure performed before surgeries involving oral cavity, pharynx, larynx, maxilla, mandible, neck, cervical spine within its surgical field. Nasotracheal intubation provides better access to these areas and a wider surgical field. Most commonly encountered problem faced during this procedure is epistaxis. To avoid it, nasal cavity has to be prepared adequately. One of the most commonly used method for preparation is topical application of vasoconstrictive agents and lubrication. Many studies have been performed regarding the choice of vasoconstrictors and comparing one with the other. We did not find any literature comparing xylometazoline and adrenaline or comparing two different concentrations of adrenaline, though both these agents have been found to maximally reduce epistaxis. So, we wish to compare between these three topical preparations and conclude the best amongst the three. Following approval by the Institutional Ethics Committee, study would be completed in the period of 18 months. After taking written and informed consent from the patient’s relative, this study would be conducted in adult patients (18-65yrs), of either sex, undergoing elective surgery requiring general anaesthesia with nasotracheal intubation. The incidence and severity of epistaxis would be noted while using three different vasoconstrictors during fiberoptic guided nasotracheal intubation. Also 24 hours post-intubation nasal discomfort and pain would be graded by VAS Score.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
180
Inclusion Criteria

Male and female patients of age 18- 65 years with American Society of Anaesthesiologists- Physical Status Grade 1 and 2 posted with indication for nasotracheal intubation i.e. undergoing surgery involving oral cavity, mandible, maxilla, thyroid, neck, difficult airway with decreased mouth opening, cervical spine, etc.

Exclusion Criteria
  1. Patients who shall not give consent 2) Patients with nasal pathology (septal deviation, turbinate hypertrophy, nasal polyp and trauma) 3) Patients with history of common cold during prior 2 weeks or treatment with nasal decongestants, anti-histamines, NSAIDS 4) Patients with coagulopathy and on anticoagulants 5) Patients with drug allergy, chronic pain syndrome, on analgesic medication 6) Pregnant patients.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Comparison of incidence and severity of epistaxis during fiberoptic-guided nasotracheal intubationAt the time of intubation
Secondary Outcome Measures
NameTimeMethod
1) Hemodynamic changes following administration of topical vasoconstrictor agents2) Patient discomfort, pain and satisfaction scoring 24 hours after extubation

Trial Locations

Locations (1)

Sanjay Gandhi Postgraduate Institute of Health Sciences

🇮🇳

Lucknow, UTTAR PRADESH, India

Sanjay Gandhi Postgraduate Institute of Health Sciences
🇮🇳Lucknow, UTTAR PRADESH, India
Shruti Somani
Principal investigator
9450344971
shrutisomani12@gmail.com

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