A Randomized Trial of 4% Nebulized Lignocaine vs. 10% Lignocaine Spray in Patients Undergoing Flexible Bronchoscopy
Condition: Patients With Indication for Flexible Bronchoscopy
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Nebulized Lignocaine; Lignocaine spray; Combined spray and nebulization
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2.5 ml of 4% lignocaine will be administered via nebulization prior to bronchoscopy; 10 puffs of 10% (10mg/puff) lignocaine spray will be sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy; 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 MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care