A Trial on Clinical Efficacy of 1% Versus 2% Lignocaine in Cough Suppression and Pain Relief in Patients Undergoing Flexible Bronchoscopy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Postgraduate Institute of Medical Education and Research
Sponsor:
Information provided by (Responsible Party):
Ritesh Agarwal, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01955824
First received: September 25, 2013
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

Flexible bronchoscopy is a common procedure performed by pulmonary physicians. The use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy varies among physicians, institutions and geographic locations across the globe. Commonly used topical anesthetic agents before and during bronchoscopy include cocaine (4%),benzocaine (20%), tetracaine (1%), and lignocaine (1%-10%). Topical lignocaine is administered through the flexible bronchoscope in an attempt to reduce excessive coughing and patient discomfort. However, the optimal dosage and strength of topical lignocaine that should be used during fibreoptic bronchoscopy has long been a topic of controversy. In this study we compare the efficacy of 1% versus 2% lignocaine in controlling cough and pain in patients undergoing flexible bronchoscopy.


Condition Intervention Phase
Lung Cancer
Tuberculosis
Sarcoidosis
Interstitial Lung Disease
Drug: 1% lignocaine
Drug: 2% lignocaine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: "A RCT ON CLINICAL EFFICACY OF 1% vs. 2% LIGNOCAINE IN COUGH SUPPRESSION AND PAIN RELIEF IN PATIENTS UNDERGOING FLEXIBLE BRONCHOSCOPY"

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Cough suppression (by Operator and Patient) [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Cough will be rated on a visual analog scale (VAS) from 0 (no cough) to 100 mm (worst cough ever)

  • Pain control [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Pain will be assessed on Wong Baker Face rating scale


Estimated Enrollment: 500
Study Start Date: May 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1% lignocaine
Each patient included in study will be nebulized prior to flexible bronchoscopy with 2.5 ml of 4% lignocaine. This will be followed by spray of 2 puffs of 10% lignocaine over the posterior pharynx and vocal cords. Lignocaine jelly (2%) will be applied in the nasal cavity. Lignocaine (1%) 8ml will be administered as "spray as you go" technique through the bronchoscope over the vocal cords, carina, right and left main bronchus as aliquots of 2 ml each. Additional requirement of lignocaine will also be recorded for all the patients.
Drug: 1% lignocaine
Active Comparator: 2% lignocaine
Each patient included in study will be nebulized prior to flexible bronchoscopy with 2.5 ml of 4% lignocaine. This will be followed by spray of 2 puffs of 10% lignocaine over the posterior pharynx and vocal cords. Lignocaine jelly (2%) will be applied in the nasal cavity. Lignocaine (2%) 8ml will be administered as "spray as you go" technique through the bronchoscope over the vocal cords, carina, right and left main bronchus as aliquots of 2 ml each. Additional requirement of lignocaine will also be recorded for all the patients.
Drug: 2% lignocaine

  Eligibility

Ages Eligible for Study:   12 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive patients undergoing flexible bronchoscopy
  • Hemodynamic stability

Exclusion Criteria:

  • Patients receiving sedatives during the course of their treatment
  • Patients undergoing conventional TBNA and/or EBUS-TBNA who are likely to receive sedation
  • Patients with known hypersensitivity to lignocaine
  • Not willing to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01955824

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
  More Information

No publications provided

Responsible Party: Ritesh Agarwal, Associate Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01955824     History of Changes
Other Study ID Numbers: Bron/Lig/Tr-1
Study First Received: September 25, 2013
Last Updated: June 3, 2014
Health Authority: India: Data safety monitoring committee, PGIMER, Chandigarh

Keywords provided by Postgraduate Institute of Medical Education and Research:
bronchoscopy
lignocaine
cough

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Tuberculosis
Sarcoidosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014