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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01955824
• Other study ID #: Bron/Lig/Tr-1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 25, 2013
• Last updated: December 26, 2014
• Start date: May 2014
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Data safety monitoring committee, PGIMER, Chandigarh
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Cancer
• Lung Diseases
• Lung Diseases, Interstitial
• Sarcoidosis
• Tuberculosis

Intervention

Drug:
• 1% lignocaine

• 2% lignocaine

Locations

Country	Name	City	State
India	Bronchoscopy suite, PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough suppression (by Operator and Patient)	Cough will be rated on a visual analog scale (VAS) from 0 (no cough) to 100 mm (worst cough ever)	15 minutes	No
Primary	Pain control	Pain will be assessed on Wong Baker Face rating scale	15 minutes	No