Effect of Xylometazoline Administration During Nasal Flexible Bronchoscopy: A Double Blind, Randomized, Placebo-controlled Trial

Xylometazoline During Nasal Flexible Bronchoscopy

Sponsors

Lead sponsor: All India Institute of Medical Sciences, New Delhi

Source All India Institute of Medical Sciences, New Delhi
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.

Overall Status Completed
Start Date June 1, 2018
Completion Date January 31, 2019
Primary Completion Date December 18, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Operator rated difficulty in nasal bronchoscope negotiation (VAS) At study completion approximately 4 months
Secondary Outcome
Measure Time Frame
Assistant rated Faces Pain scale for discomfort on nasal bronchoscope insertion At study completion approximately 4 months
Patient rated nasal pain on procedure completion (VAS) At study completion approximately 4 months
Operator rated nasal mucosal trauma (VAS) At study completion approximately 4 months
Complications At study completion approximately 4 months
Enrollment 148
Condition
Intervention

Intervention type: Drug

Intervention name: Xylometazoline

Description: Nasal administration of Xylometazoline

Arm group label: Xylometazoline

Intervention type: Drug

Intervention name: Saline

Description: Nasal administration of 0.9% Saline

Arm group label: Saline placebo

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Karan Madan, MD, DM Principal Investigator All India Institute of Medical Sciences, New Delhi
Location
facility
AIIMS
AIIMS
Location Countries

India

Verification Date

March 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: All India Institute of Medical Sciences, New Delhi

Investigator full name: Karan Madan

Investigator title: Karan Madan, MD DM, Assistant Professor, Pulmonary Medicine and Sleep Disorders

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Xylometazoline

Arm group type: Experimental

Description: Patients receiving topical xylometazoline nasally during bronchoscopy

Arm group label: Saline placebo

Arm group type: Placebo Comparator

Description: Patients receiving topical saline nasally during bronchoscopy

Acronym VAIN
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Randomized, double blind, placebo controlled

Primary purpose: Health Services Research

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking description: Concealed envelopes

Source: ClinicalTrials.gov