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

NCT03040193 | Completed DMC

• 1 other identifier: Ref.No.IEC-594/05.01.2017
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bronchopulmonary Disease

Keywords

Lignocaine

Outcome Measures

Primary Outcomes (2)

• Operator rated overall procedure satisfaction VAS

  At study completion approx. 12 months

• Operator rated cough VAS

  At study completion approx. 12 months

Secondary Outcomes (2)

• Total dose of Lignocaine administered (mg)

  At study completion approx. 12 months

• Number of patients receiving dose >8.2mg/Kg

  At study completion approx. 12 months

Study Arms (2)

Nebulized Lignocaine

EXPERIMENTAL

4% Lignocaine administered as nebulization for topical anaesthesia during bronchoscopy procedure

Drug: Lignocaine Nebulization

Nebulized Saline

PLACEBO COMPARATOR

Normal Saline administered as nebulization for topical anaesthesia during bronchoscopy procedure

Drug: Saline Nebulization

Interventions

Lignocaine Nebulization DRUG

4% Lignocaine delivered via Nebulization

Nebulized Lignocaine

Saline Nebulization DRUG

Normal Saline Delivered via Nebulization

Nebulized Saline

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

Study Officials

• Randeep Guleria, MD, DM

  AIIMS, New Delhi

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 2, 2017
• Study Start: March 15, 2017
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: January 30, 2018

Record last verified: 2018-01

Locations

IN (1)