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

All India Institute Of Medical Science (AIIMS)

Status: Completed

Conditions: Bronchopulmonary Disease

Treatments: Drug: Saline Nebulization; Drug: Lignocaine Nebulization

Study type: Interventional

Funder types: Other

Identifiers

NCT03040193

Ref.No.IEC-594/05.01.2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Nebulized Lignocaine

Experimental group

Description:

4% Lignocaine administered as nebulization for topical anaesthesia during bronchoscopy procedure

Treatment:

Drug: Lignocaine Nebulization

Nebulized Saline

Placebo Comparator group

Description:

Normal Saline administered as nebulization for topical anaesthesia during bronchoscopy procedure

Treatment:

Drug: Saline Nebulization