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

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ClinicalTrials.gov Identifier: NCT03109392
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Ritesh Agarwal, Postgraduate Institute of Medical Education and Research

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.

Condition or disease Intervention/treatment Phase
Patients With Indication for Flexible Bronchoscopy Drug: Nebulized Lignocaine Drug: Lignocaine spray Drug: Combined spray and nebulization Phase 2 Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized-controlled Trial to Compare the Effectiveness of 4% Nebulized Lignocaine Versus 10% Lignocaine Spray in Patients Undergoing Flexible Bronchoscopy
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: Nebulized lignocaine
2.5 ml of 4% lignocaine will be administered via nebulization prior to bronchoscopy
Drug: Nebulized Lignocaine
2.5 ml of 4% lignocaine will be administered via nebulization prior to bronchoscopy

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

Active Comparator: 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
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109392


Contacts
Contact: Ritesh Agarwal, MD, DM 0172-2756825 agarwal.ritesh@outlook.in
Contact: Inderpau S Sehgal, MD, DM 0172-2756823 inderpgi@outlook.com

Locations
India
Bronchoscopy suite, PGIMER Recruiting
Chandigarh, India, 160012
Contact: Ritesh Agarwal, MD, DM    0172-2756825    riteshpgi@gmail.com   
Contact: Ashutosh N Aggarwal, MD, DM    0172-2756824    dr.anaggarwal@gmail.com   
Principal Investigator: Ritesh Agarwal, MD, DM         
Sub-Investigator: Ashutosh N Aggarwal, MD, DM         
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research

Responsible Party: Ritesh Agarwal, Consultant, Department of Pulmonary Medicine, Principal Investigator, Clinical Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03109392     History of Changes
Other Study ID Numbers: Pulm.Med/2017/001
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action