1% vs. 2 % Lignocaine for Endobronchial Ultrasound Guided Transbronchial Needle Aspiration

NCT02913300 | Completed DMC

• 1 other identifier: Lignocaine EBUS RCT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly performed for diagnosis of mediastinal pathologies. The procedure can either be performed under general anaesthesia or under moderate sedation with topical anaesthesia. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is no literature on the efficacy of lower concentrations (1%) versus a higher (2%) during EBUS TBNA. This study would help to determine whether 1% lignocaine is as effective as 2% lignocaine for airway anaesthesia during EBUS-TBNA.

Conditions

Bronchopulmonary Diseases

Keywords

Lignocaine

Outcome Measures

Primary Outcomes (2)

• Operator rated cough VAS

  At study completion approximately 6 months

• Operator rated overall procedure satisfaction VAS

  At study completion approximately 6 months

Secondary Outcomes (3)

• Total lignocaine dose administered

  At study completion approximately 6 months

• Patient facies pain rating scale

  At study completion approximately 6 months

• Procedure related adverse events

  At study completion approximately 6 months

Study Arms (2)

1 % Lignocaine

ACTIVE COMPARATOR

1 % Lignocaine administered for topical anaesthesia during EBUS-TBNA

Drug: Lignocaine 1% concentration solution

2 % Lignocaine

ACTIVE COMPARATOR

2 % Lignocaine administered for topical anaesthesia during EBUS-TBNA

Drug: Lignocaine 2% concentration solution

Interventions

Lignocaine 1% concentration solution DRUG

1 % Lignocaine

Lignocaine 2% concentration solution DRUG

2 % Lignocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for diagnostic or therapeutic flexible bronchoscopy
• Age \> 18 years

You may not qualify if:

• Refusal of consent
• Known documented hypersensitivity to lignocaine
• Procedure performed under general anaesthesia
• Pregnancy
• Hypoxemia (oxygen saturation \[by pulse oximetry\] \< 92% with Fio2 of ≥ 0.3

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Randeep Guleria, MD, DM

  All India Institute of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Karan Madan, MD, DM Assistant Professor, Pulmonary Medicine and Sleep Disorders

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 23, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

IN (1)