5 Versus 10 Sprays of Lignocaine for Pharyngeal Anaesthesia During Bronchoscopy

Study Overview
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Brief Summary
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Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be significantly improved with control of cough. Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is uncertainty regarding the adequate dose of lignocaine sprays for pharyngeal anaesthesia during flexible bronchoscopy. This study would help to determine the optimal dose of lignocaine sprays for pharyngeal anaesthesia during flexible bronchoscopy.

Detailed Description
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For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. Enrolled patients will be randomized to receive either 5 or 10 sprays of 10% lignocaine to the pharynx. This will be followed by the standard topical anesthesia procedure followed in our institution involving 5ml of 2% lignocaine gel into the nostril. Transnasal flexible bronchoscopy will be performed with additional 1% lignocaine administered as spray as you go method. This will be given as 2 ml aliquots- with similar volume in both groups as baseline. Procedure shall be performed with administration of sedation using Midazolam and Fentanyl if required. Primary outcome will be assessed by noting the operator rated overall procedure satisfaction as a VAS scale score.

Official Title
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A Randomized Controlled Trial to Evaluate the Efficacy of Topical Pharyngeal Anaesthesia Using 5 vs 10 Sprays of 10% Lignocaine During Flexible Bronchoscopy

Conditions
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Bronchoscopy, Anesthesia, Local

Intervention / Treatment
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* Drug: 5 sprays of 10% lignocaine
* Drug: 10 sprays of 10% lignocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adults ≥ 18 yrs of age undergoing flexible bronchoscopy Exclusion Criteria: Uncontrolled hypertension Systolic Blood Pressure >180 mm Hg Symptomatic coronary artery disease Pregnancy Not giving informed consent for the procedure Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3 Bronchoscopy performed through an artificial airway

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5 sprays<br>5 sprays of 10% lignocaine administered for topical anaesthesia during flexible bronchoscopy | Drug: 5 sprays of 10% lignocaine<br>* 5 sprays of 10% lignocaine<br>* Other names: 5 sprays;|
| Experimental: 10 sprays<br>10 sprays of 10% lignocaine administered for topical anaesthesia during flexible bronchoscopy | Drug: 10 sprays of 10% lignocaine<br>* 10 sprays of 10% lignocaine<br>* Other names: 10 sprays;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operator rated overall procedure satisfaction | Visual Analogue Scale score (VAS) between 0 to 100 | At study completion at approximately 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operator rated cough | Visual Analogue score (VAS) between 0 to 100 | At study completion at approximately 4 months | 
| Time from bronchoscope introduction to reaching the vocal cords | Time in seconds | At study completion at approximately 4 months | 
| Patient willingness to return for repeat bronchoscopy | Proportion of patients willing for repeat bronchoscopy in each group | At study completion at approximately 4 months | 
| Cumulative lignocaine dose | Total dose of lignocaine in milligram (mg) | At study completion at approximately 4 months | 
| Complications | Proportion of patients with complications in each group | At study completion at approximately 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bronchoscopy, lignocaine