An interventional study of Xylometazoline and Saline in Bronchoscopy, sponsored by All India Institute of Medical Sciences, New Delhi. Completed at 2 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-11.
Sponsored by All India Institute of Medical Sciences, New Delhi · Not applicable, Interventional, and Health services research
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.
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:
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.
All India Institute of Medical Sciences, New Delhi is the lead sponsor of 143 studies on the registry; 13 are open to participants now.
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Exclusion criteria:
Patients receiving topical xylometazoline nasally during bronchoscopy
Drug: Xylometazoline
Patients receiving topical saline nasally during bronchoscopy
Drug: Saline
Nasal administration of Xylometazoline
Nasal administration of 0.9% Saline
Operator rated difficulty in nasal bronchoscope negotiation (VAS)
Visual Analogue scale
Time frame: At study completion approximately 4 months
Assistant rated Faces Pain scale for discomfort on nasal bronchoscope insertion
10 point scale divided into six categories
Time frame: At study completion approximately 4 months
Patient rated nasal pain on procedure completion (VAS)
Visual Analogue scale
Time frame: At study completion approximately 4 months
Operator rated nasal mucosal trauma (VAS)
Visual Analogue scale
Time frame: At study completion approximately 4 months
Complications
Proportion of patients developing complications
Time frame: At study completion approximately 4 months
Plan to share: No
Ran from Jun 2018 to primary completion in Dec 2018, 6 months.
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Xylometazoline
All India Institute of Medical Sciences, New Delhi →