NCT03869528

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. Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is uncertainty regarding the adequate dose of lignocaine sprays for pharyngeal anaesthesia during flexible bronchoscopy. This study would help to determine the optimal dose of lignocaine sprays for pharyngeal anaesthesia during flexible bronchoscopy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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 8, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

2.7 years

First QC Date

March 8, 2019

Last Update Submit

January 13, 2021

Conditions

BronchoscopyAnesthesia, Local

Keywords

bronchoscopylignocaine

Outcome Measures

Primary Outcomes (1)

  • Operator rated overall procedure satisfaction

    Visual Analogue Scale score (VAS) between 0 to 100

    At study completion at approximately 4 months

Secondary Outcomes (5)

  • Operator rated cough

    At study completion at approximately 4 months

  • Time from bronchoscope introduction to reaching the vocal cords

    At study completion at approximately 4 months

  • Patient willingness to return for repeat bronchoscopy

    At study completion at approximately 4 months

  • Cumulative lignocaine dose

    At study completion at approximately 4 months

  • Complications

    At study completion at approximately 4 months

Study Arms (2)

5 sprays

ACTIVE COMPARATOR

5 sprays of 10% lignocaine administered for topical anaesthesia during flexible bronchoscopy

Drug: 5 sprays of 10% lignocaine

10 sprays

EXPERIMENTAL

10 sprays of 10% lignocaine administered for topical anaesthesia during flexible bronchoscopy

Drug: 10 sprays of 10% lignocaine

Interventions

5 sprays of 10% lignocaineDRUG

5 sprays of 10% lignocaine

Also known as: 5 sprays
5 sprays
10 sprays of 10% lignocaineDRUG

10 sprays of 10% lignocaine

Also known as: 10 sprays
10 sprays

Eligibility Criteria

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

You may qualify if:

  • All adults ≥ 18 yrs of age undergoing flexible bronchoscopy

You may not qualify if:

  • Uncontrolled hypertension Systolic Blood Pressure \>180 mm Hg
  • Symptomatic coronary artery disease
  • Pregnancy
  • Not giving informed consent for the procedure
  • Hypoxemia (oxygen saturation \[by pulse oximetry\] \< 92% with Fio2 of ≥ 0.3
  • Bronchoscopy performed through an artificial airway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AIIMS

New Delhi, 110029, India

RECRUITING

AIIMS Rishikesh

Rishikesh, India

RECRUITING

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Randeep Guleria, MD DM

    AIIMS, New Delhi

    STUDY CHAIR

Central Study Contacts

Karan Madan, MD DM

CONTACT

00911126593488drkaranmadan@gmail.com

Anant Mohan, MD

CONTACT

00911126593006anantmohan@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Group allocation by opaque sealed envelopes. Participant and bronchoscopist shall be unaware of the number of sprays administered.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Karan Madan, Assistant Professor, Department of Pulmonary Medicine and Sleep Disorders

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 11, 2019

Study Start

April 1, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

IN(2)