Clinical trial NCT03424889: Xylometazoline During Nasal Flexible Bronchoscopy
Official title: Effect of Xylometazoline Administration During Nasal Flexible Bronchoscopy: A Double Blind, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchoscopy
Keywords: Bronchoscopy
Lignocaine
Anaesthesia
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blind, placebo controlled
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Flexible bronchoscopy is a commonly performed procedure and is usually performed transnasally. The optimal topical anesthesia regimen for bronchoscopy is investigational. Topical Vasoconstrictors like xylometazoline produce decongestion of nasal mucosa and may make insertion of bronchoscope easier. The addition of topical vasoconstrictor to lignocaine may have advantage in terms of patient comfort and for reducing local complications. Although evaluated in the settings of nasal endoscopy and nasotracheal intubation, randomized trials on the role of topical vasoconstrictors during flexible bronchoscopy are not available. The aim of this randomized trial is to study the effect of topical nasal xylometazoline administration during flexible bronchoscopy.

Detailed description: Study design: Randomized double-blind placebo controlled study Study setting: Bronchoscopy room in Department of pulmonary medicine and sleep disorders at AIIMS, New Delhi Sample size: 200 patients (100 in each arm)

Inclusion criteria:

a) All adults \> 18 years of age undergoing flexible bronchoscopy via nasal route

Exclusion criteria:

1. Uncontrolled hypertension
2. coronary artery disease

b) Pregnancy c) refusal of consent d) Hypoxemia (oxygen saturation \[by pulse oximetry\] \< 92% with Fio2 of ≥ 0.3 e) Bronchoscopy not performed by nasal route f) Bronchoscopy performed through an artificial airway

Randomisation:

Computer generated Block randomisation with block size of 10 will be used to generate list of random numbers based on which subjects will be allocated to either of the groups.

Procedure of study The operator, assistant, drug administrator and outcomes assessor will be blinded. Patients meeting eligibility criteria will be randomized to receive either study drug Xylometazoline (0.1% nasal drops) (Otrivin, Novartis) (3 drops into each nostril) or 0.9% saline (3 drops into each nostril) placebo. This will be administered as ten minutes before bronchoscopy. This will be followed by the standard topical anesthesia procedure followed in our institution involving 5ml of 2% lignocaine gel into the nostril and 4 sprays of 10% lignocaine to the pharynx. Nebulized lignocaine shall not be administered. Transnasal flexible bronchoscopy will be performed with additional 1% lignocaine solution administered as "spray as you go" method. All diagnostic procedures or airway inspection procedures will be included. Patients shall undergo hemodynamic monitoring throughout the procedure. Procedures shall be performed without administration of upfront sedation and intraprocedural sedation shall be at the discretion of the operator.

Data will be recorded on a predesigned proforma. Baseline patient characteristics will be compared between the two groups. Categorical variables will be summarised by frequency (%) and chi-square test of proportion will be used to compare between the two groups.Quantitative variables will be summarised by mean±SD or median(IQR),as appropriate. Student's t-test or Wilcoxon rank sum test as appropriately be used to compare distribution of quantitative variables between the two groups. Stata statistical software will be used for data analysis.

Eligibility criteria: Inclusion Criteria:

- All adults \> 18 years of age undergoing flexible bronchoscopy via nasal route

Exclusion criteria:

* Uncontrolled hypertension
* coronary artery disease
* Pregnancy
* refusal of consent
* Hypoxemia (oxygen saturation \[by pulse oximetry\] \< 92% with Fio2 of ≥ 0.3
* Bronchoscopy not performed by nasal route
* Bronchoscopy performed through an artificial airway

Primary outcomes:
measure: Operator rated difficulty in nasal bronchoscope negotiation (VAS)
timeFrame: At study completion approximately 4 months
Secondary outcomes:
measure: Assistant rated Faces Pain scale for discomfort on nasal bronchoscope insertion
timeFrame: At study completion approximately 4 months
measure: Patient rated nasal pain on procedure completion (VAS)
timeFrame: At study completion approximately 4 months
measure: Operator rated nasal mucosal trauma (VAS)
timeFrame: At study completion approximately 4 months
measure: Complications
timeFrame: At study completion approximately 4 months
Other outcomes:
Locations:
city: Delhi
country: India
facility: AIIMS
state: New Delhi
city: New Delhi
country: India
facility: AIIMS
Study officials:
affiliation: All India Institute of Medical Sciences
name: Karan Madan, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sryma PB, Mittal S, Tiwari P, Mohan A, Hadda V, Guleria R, Madan K. Topical nasal xylometazoline for flexible bronchoscopy (VAIN): A randomized, double-blind, placebo-controlled trial. Respir Investig. 2021 May;59(3):350-355. doi: 10.1016/j.resinv.2020.12.004. Epub 2021 Jan 29.