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Completed

NCT Number: NCT03109392

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Bronchoscopy suite, PGIMER

Chandigarh, 160012, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nebulized Lignocaine

Drug

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

Lignocaine spray

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

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

Primary outcomes

  1. Patient-rated intensity of cough on a visual analog scale (VAS)

    Time frame: One hour

    The cough VAS is a 100-mm scale anchored by no cough on one end and worst cough on the other; the patient will indicate the severity of a cough by marking a line.

Secondary outcomes

  1. Pain assessment by the patient using the faces pain rating scale

    Time frame: One hour

    The Wong-Baker Faces Pain Scale combines the pictures and numbers to allow pain to be rated by the user. The faces range from smiling face to a sad, crying face. A numerical rating is assigned to each face, of which there is 6 total, where zero rating means no pain with smiling face and 10 mean worst pain with crying face

  2. Patient-rated VAS of overall satisfaction of the procedure

    Time frame: One hour

    VAS on a 100-mm scale

  3. Operator-rated intensity of cough on a VAS

    Time frame: Immediately following the procedure

    VAS on a 100-mm scale

  4. Total lignocaine dose

    Time frame: Immediately following the procedure

    Total dose of lignocaine in milligrams

  5. Changes in respiratory rate following the procedure

    Time frame: Baseline and 5 minutes after the procedure

    Respiratory rate at baseline and 5 minutes after the procedure

  6. Changes in heart rate following the procedure

    Time frame: Baseline, during and 5 minutes after the procedure

    Heart rate at baseline, during and 5 minutes after the procedure

  7. Changes in blood pressure following the procedure

    Time frame: Baseline and 5 minutes after the procedure

    Blood pressure at baseline and 5 minutes after the procedure

  8. Changes in oxygenation status following the procedure

    Time frame: Baseline, during and 5 minutes after the procedure

    Pulse oximetric saturation at baseline, during and 5 minutes after the procedure

  9. Duration of procedure (in minutes)

    Time frame: Immediately following the completion of flexible bronchoscopy

    The total duration of bronchoscopy procedure in minutes

  10. Willingness of the patient to undergo the procedure yet again, if required

    Time frame: One hour

    Patient will indicate the willingness to undergo the procedure again, if required by a simple yes or no

  11. Adverse reactions related to lignocaine

    Time frame: One hour

    Arrhythmia, involuntary movements, convulsions, anaphylaxis and bronchospasm

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

A Randomized-controlled Trial to Compare the Effectiveness of 4% Nebulized Lignocaine Versus 10% Lignocaine Spray in Patients Undergoing Flexible Bronchoscopy

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2017
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.