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Clinical Trials/NCT01955824
NCT01955824
Completed
Phase 2

"A RCT ON CLINICAL EFFICACY OF 1% vs. 2% LIGNOCAINE IN COUGH SUPPRESSION AND PAIN RELIEF IN PATIENTS UNDERGOING FLEXIBLE BRONCHOSCOPY"

Post Graduate Institute of Medical Education and Research, Chandigarh1 site in 1 country500 target enrollmentMay 2014

Overview

Phase
Phase 2
Intervention
1% lignocaine
Conditions
Lung Cancer
Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Enrollment
500
Locations
1
Primary Endpoint
Cough suppression (by Operator and Patient)
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
November 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Responsible Party
Principal Investigator
Principal Investigator

Ritesh Agarwal

Associate Professor

Post Graduate Institute of Medical Education and Research, Chandigarh

Eligibility 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

Arms & Interventions

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.

Intervention: 1% lignocaine

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.

Intervention: 2% lignocaine

Outcomes

Primary Outcomes

Cough suppression (by Operator and Patient)

Time Frame: 15 minutes

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

Pain will be assessed on Wong Baker Face rating scale

Study Sites (1)

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