Nebulized Lignocaine for Topical Airway Anesthesia During Flexible Bronchoscopy: A Randomized Controlled Trial

Bronchopulmonary Disease Clinical Trial

— NEBULA  

Official title:

Nebulized Lignocaine for Topical Airway Anesthesia During Flexible Bronchoscopy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03040193
• Other study ID #: Ref.No.IEC-594/05.01.2017
• Status: Completed
• Phase: N/A
• First received: January 31, 2017
• Last updated: January 28, 2018
• Start date: March 15, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: January 2018
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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. Use of sedation during bronchoscopy has been reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is routinely performed at many centres including ours.

Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is limited literature on the efficacy of lignocaine delivered with the nebulized route during awake flexible bronchoscopy. This study would help to determine the utility of nebulized lignocaine in airway anaesthesia during flexible bronchoscopy.

Description:

For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo flexible bronchoscopy would be randomised in a one is to one ratio either to nebulized lignocaine (4%) or saline (placebo) nebulization group. Prior to the bronchoscopy blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded at the baseline Patients in both the groups shall be prepared in a similar fashion except for the nebulized lignocaine. Patient, Operator, outcome assessor will be blinded to the allocation.

During the procedure, 1.5ml aliquots of 1% lignocaine will be delivered through the bronchoscope using spray-as-you go technique. The patients would be monitored for any adverse effects throughout the procedure. The bronchoscopist doing the procedure will be provided 2 VAS charts to mark the severity of cough and overall procedure satisfaction.

Post procedure, patients will record the pain experienced while undergoing the procedure on the faces pain rating scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (Age > 18 years) patients undergoing diagnostic or therapeutic flexible bronchoscopy

Exclusion Criteria:

1. Pregnancy

2. Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of = 0.3

3. Bronchoscopy done through endotracheal or tracheostomy tube

4. Not willing to provide informed consent.

5. Patient requiring sedation for flexible bronchoscopy

6. Patients with known allergy to lignocaine -

Related Conditions & MeSH terms

• Bronchopulmonary Disease

Intervention

Drug:
• Lignocaine Nebulization
4% Lignocaine delivered via Nebulization
• Saline Nebulization
Normal Saline Delivered via Nebulization

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operator rated overall procedure satisfaction VAS		At study completion approx. 12 months
Primary	Operator rated cough VAS		At study completion approx. 12 months
Secondary	Total dose of Lignocaine administered (mg)		At study completion approx. 12 months
Secondary	Number of patients receiving dose >8.2mg/Kg		At study completion approx. 12 months