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OpenTrials
Completed

NCT Number: NCT03040193

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

All India Institute of Medical Sciences

New Delhi, 110029, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult (Age > 18 years) patients undergoing diagnostic or therapeutic flexible bronchoscopy

Exclusion criteria

  • Pregnancy
  • Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3
  • Bronchoscopy done through endotracheal or tracheostomy tube
  • Not willing to provide informed consent.
  • Patient requiring sedation for flexible bronchoscopy
  • Patients with known allergy to lignocaine -

Treatment and study plan

Lignocaine Nebulization

Drug

4% Lignocaine delivered via Nebulization

Saline Nebulization

Drug

Normal Saline Delivered via Nebulization

Primary outcomes

  1. Operator rated overall procedure satisfaction VAS

    Time frame: At study completion approx. 12 months

  2. Operator rated cough VAS

    Time frame: At study completion approx. 12 months

Secondary outcomes

  1. Total dose of Lignocaine administered (mg)

    Time frame: At study completion approx. 12 months

  2. Number of patients receiving dose >8.2mg/Kg

    Time frame: At study completion approx. 12 months

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Acronym: NEBULA

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 2, 2017
Registry last updated
Jan 30, 2018

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.

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