Xylometazoline During Nasal Flexible Bronchoscopy

NCT ID: NCT03424889

Last Updated: 2019-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-01-31

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.

Conditions

Bronchoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

Xylometazoline

Patients receiving topical xylometazoline nasally during bronchoscopy

Group Type: EXPERIMENTAL

Xylometazoline

Intervention Type: DRUG

Nasal administration of Xylometazoline

Saline placebo

Patients receiving topical saline nasally during bronchoscopy

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Nasal administration of 0.9% Saline

Interventions

Xylometazoline

Nasal administration of Xylometazoline

Intervention Type: DRUG

Saline

Nasal administration of 0.9% Saline

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Karan Madan

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karan Madan, MD, DM

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Locations

AIIMS

Delhi, New Delhi, India

AIIMS

New Delhi, , India

Countries

India

References

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.

Reference Type: DERIVED

PMID: 33518471 (View on PubMed)

Other Identifiers

IEC AIIMS/Vasoconstrictor RCT

Identifier Type: -

Identifier Source: org_study_id