A Randomized Trial of 4% Nebulized Lignocaine vs. 10% Lignocaine Spray in Patients Undergoing Flexible Bronchoscopy

NCT ID: NCT03109392

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1050 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-06-30

Brief Summary

Flexible bronchoscopy is common procedure used in the diagnosis and treatment of a variety of tracheobronchial diseases. During routine diagnostic flexible bronchoscopy, the most distressing symptom experienced by the patients is a cough, and control of a cough is vital for a successful procedure. The investigators hypothesized that either nebulized lignocaine or lignocaine spray given alone prior to flexible bronchoscopy for inducing topical anesthesia will have similar efficacy compared to the combination of the two agents.

Detailed Description

Flexible bronchoscopy is common procedure used in the diagnosis and treatment of a variety of tracheobronchial diseases. The bronchoscope can be used to sample material not only from the visualized regions but also from the more distal pulmonary parenchyma. It is a safe outpatient exam that carries little risk. While performing the procedure most of the patients express some fear of pain, difficulty in breathing, nasopharyngeal irritation, and cough. During routine diagnostic flexible bronchoscopy, the most distressing symptom experienced by the patients is a cough, and control of a cough is vital for a successful procedure. Administration of a topical anaesthetic drug to the upper airway, larynx, and tracheobronchial tree can reduce a cough and patient's discomfort. The most commonly used topical anaesthetic agent in bronchoscopy is lignocaine because of its quick onset and short duration of action with decreased toxicity as compared to other agents. There are several ways to achieve topical anaesthesia in flexible bronchoscopy including nebulization, direct spray, by tracheal injection, or via nasal, or "spray as you go" technique through the working channel of the bronchoscope. The use of topical anaesthesia, sedation, and analgesia during flexible bronchoscopy varies according to physicians, institutions and geographic locations in the world. Generally, moderate sedation is used in bronchoscopy in which patients can respond to verbal commands. Deep sedation is less commonly used in which patients cannot be easily aroused but respond to repeated or painful stimulation.

Antoniades et al. demonstrated that topical lidocaine through the bronchoscope significantly decreased cough frequency and the total dose of sedation required during flexible bronchoscopy. In a randomized controlled trial of 54 patients, Keane et al. concluded that nebulized and sprayed lignocaine have similar efficacy as topical anaesthetics in fiberoptic bronchoscopy but patients preferred the nebulized route. Noitasaeng et.al. concluded in their study that spraying lidocaine took less time to start the procedure, with greater ease of instrumentation, less incidence of hypersecretion, less gag reflex, and smooth operation during the procedure but patients preferred nebulized lidocaine administration.

At the investigators' center, it has been a routine practice to perform flexible bronchoscopy without sedation in patients who require only diagnostic flexible bronchoscopy and assessment of airway anatomy and other routine procedures such as endobronchial biopsy or transbronchial biopsy. Previously, the investigators had shown that 1% lignocaine given by spray-as-you-go method was similar in efficacy to 2% lignocaine for topical anesthesia during routine flexible bronchoscopy. However, in this study both the groups received nebulized lignocaine and lignocaine spray prior to flexible bronchoscopy in addition to lignocaine solution ad lib.

The investigators hypothesized that either nebulized lignocaine or lignocaine spray given alone prior to flexible bronchoscopy for inducing topical anesthesia will have similar efficacy compared to the combination of the two agents.

Conditions

Patients With Indication for Flexible Bronchoscopy

Study Design

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

Study Groups

Nebulized lignocaine

2.5 ml of 4% lignocaine will be administered via nebulization prior to bronchoscopy

Group Type: EXPERIMENTAL

Nebulized Lignocaine

Intervention Type: DRUG

2.5 ml of 4% lignocaine will be administered via nebulization prior to bronchoscopy

Lignocaine spray

10 puffs of 10% (10mg/puff) lignocaine spray will be sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy

Group Type: EXPERIMENTAL

Lignocaine spray

Intervention Type: DRUG

10 puffs of 10% (10mg/puff) lignocaine spray will be sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy

Combined spray and nebulization

Combination of 2.5 ml of 4% lignocaine via nebulization prior to bronchoscopy and 2 puffs of 10% (10mg/puff) lignocaine spray sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy

Group Type: ACTIVE_COMPARATOR

Combined spray and nebulization

Intervention Type: DRUG

Combination of 2.5 ml of 4% lignocaine via nebulization prior to bronchoscopy and 2 puffs of 10% (10mg/puff) lignocaine spray sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy

Interventions

Nebulized Lignocaine

2.5 ml of 4% lignocaine will be administered via nebulization prior to bronchoscopy

Intervention Type: DRUG

Lignocaine spray

10 puffs of 10% (10mg/puff) lignocaine spray will be sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy

Intervention Type: DRUG

Combined spray and nebulization

Combination of 2.5 ml of 4% lignocaine via nebulization prior to bronchoscopy and 2 puffs of 10% (10mg/puff) lignocaine spray sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years
• Willing for flexible bronchoscopy procedure a

Exclusion Criteria

• Requirement of intravenous sedation to undergo any procedure including EBUS-TBNA, conventional TBNA, radial EBUS procedure and interventional pulmonary procedures
• Sensitivity to lignocaine
• Hemodynamically unstable patients (SBP < 90 mm Hg)
• Baseline hypoxemia (SpO2 <92% on room air)
• Pregnancy
• Comorbid illness such as heart failure, CKD, chronic liver disease and others
• Failure to provide informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Ritesh Agarwal

Consultant, Department of Pulmonary Medicine, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bronchoscopy suite, PGIMER

Chandigarh, , India

Countries

India

References

Dhooria S, Chaudhary S, Ram B, Sehgal IS, Muthu V, Prasad KT, Aggarwal AN, Agarwal R. A Randomized Trial of Nebulized Lignocaine, Lignocaine Spray, or Their Combination for Topical Anesthesia During Diagnostic Flexible Bronchoscopy. Chest. 2020 Jan;157(1):198-204. doi: 10.1016/j.chest.2019.06.018. Epub 2019 Jul 9.

Reference Type: DERIVED

PMID: 31299247 (View on PubMed)

Other Identifiers

Pulm.Med/2017/001

Identifier Type: -

Identifier Source: org_study_id