NCT03040193

Completed

Nebulized Lignocaine for Topical Airway Anesthesia During Fl...

All India Institute of Medical Sciences Source

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Other study identifiers

Sponsor study identifier

Ref.No.IEC-594/05.01.2017

Study Type

interventional

Actual enrollment (reported)

200

Locations

1 country

Sites

1

Timeline

Study Start

March 15, 2017

Actual (reported)

Primary Completion

December 15, 2017

Actual (reported)

Study Completion

December 15, 2017

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 200 participants
Study completion date: December 15, 2017
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
January 31, 2017
Actual (reported)
First Posted
February 2, 2017
Actual (reported)
Study Start
March 15, 2017
Actual (reported)
Primary Completion
December 15, 2017
Actual (reported)
Study Completion
December 15, 2017
Actual (reported)

Last Updated: January 30, 2018
Status Verified: January 2018
Last Update Submitted: January 28, 2018

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 NebulizationDrug

4% Lignocaine delivered via Nebulization

Nebulized Lignocaine

Saline NebulizationDrug

Normal Saline Delivered via Nebulization

Nebulized Saline

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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:

Sponsors & Collaborators

All India Institute of Medical Sciences
Otherlead

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, 110029, India

Study Officials

Randeep Guleria, MD, DM
All India Institute of Medical Sciences
STUDY CHAIR

Enrollment

200 participants (actual enrollment reported by the registry).

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

Actual (reported)

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Not ApplicableCompleted

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Lidocaine Reduces Muscle Tremor is Beneficial for Intraoperative Recurrent Laryngeal Nerve Monitoring

Not ApplicableUnknown

NCT02708433

Clinical Outcomes of Buffered 1% Lidocaine vs. Non-buffered 2% Lidocaine

Not ApplicableCompleted

NCT00840918

Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery

Not ApplicableTerminated

NCT02590705

Anesthesia Lumbar Puncture In Children

Not ApplicableUnknown

NCT02620501

Does Use of Topical Lidocaine in EGD Reduce Amount of IV Midazolam and Fentanyl Required and Shorten Recovery Time

Not ApplicableUnknown

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 -

Contact the study team to confirm eligibility.

Primary Completion

December 15, 2017

Actual (reported)

Study Completion

December 15, 2017

Actual (reported)

Last Updated

January 30, 2018

Record last verified: 2018-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03040193
Data provider: ClinicalTrials.gov
Source updated: 2018-01-30
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:34 UTC

Locations

IN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

Nebulized Lignocaine

Nebulized Saline

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations