NCT02701179

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 lower concentrations (1%) versus a higher (2%) during bronchoscopic procedures. This study would help to determine whether 1% lignocaine is as effective as 2% lignocaine for airway anaesthesia during flexible bronchoscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

March 2, 2016

Last Update Submit

August 21, 2017

Conditions

Bronchopulmonary Diseases

Keywords

Lignocaine

Outcome Measures

Primary Outcomes (2)

  • Operator rated cough VAS

    At study completion approximately 12 months

  • Operator rated overall procedure satisfaction VAS

    At study completion approximately 12 months

Secondary Outcomes (3)

  • Total lignocaine dose administered

    At study completion approximately 12 months

  • Patient facies pain rating scale

    At study completion approximately 12 months

  • Procedure related adverse events

    At study completion approximately 12 months

Study Arms (2)

1 % Lignocaine

ACTIVE COMPARATOR

1 % Lignocaine administered for topical anaesthesia during bronchoscopy procedure

Drug: Lignocaine 1% concentration solution

2 % Lignocaine

ACTIVE COMPARATOR

2 % Lignocaine administered for topical anaesthesia during bronchoscopy procedure

Drug: Lignocaine 2% concentration solution

Interventions

Lignocaine 1% concentration solutionDRUG
1 % Lignocaine
Lignocaine 2% concentration solutionDRUG
2 % Lignocaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for diagnostic or therapeutic flexible bronchoscopy
  • Age \> 18 years
  • Hemodynamic stability (defined as systolic BP \>100 mm Hg and, \<180 mm Hg).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

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

March 2, 2016

First Posted

March 8, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

IN(1)