5 Versus 10 Sprays of Lignocaine for Pharyngeal Anaesthes... | NCT03869528

Studies
5 Versus 10 Sprays of Lignocaine for Pharyngeal Anaesthesia During Bronchoscopy

NCT03869528

Sponsor

All India Institute of Medical Sciences

Status

Unknown status

Last Update Posted

Jan 15, 2021Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Bronchoscopy
Anesthesia, Local

Interventions

5 sprays of 10% lignocaine
10 sprays of 10% lignocaine

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Dec 1, 2021Estimated

First Submitted Date

Mar 8, 2019

First Submission Date that Met QC Criteria

Mar 8, 2019

First Posted Date

Mar 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2021

Last Update Posted Date

Jan 15, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Karan Madan, Dr Karan Madan, Assistant Professor, Department of Pulmonary Medicine and Sleep Disorders, All India Institute of Medical SciencesPrincipal Investigator

Lead Sponsor

All India Institute of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. Enrolled patients will be randomized to receive either 5 or 10 sprays of 10% lignocaine to the pharynx. This will be followed by the standard topical anesthesia procedure followed in our institution involving 5ml of 2% lignocaine gel into the nostril. Transnasal flexible bronchoscopy will be performed with additional 1% lignocaine administered as "spray as you go" method. This will be given as 2 ml aliquots- with similar volume in both groups as baseline. Procedure shall be performed with administration of sedation using Midazolam and Fentanyl if required. Primary outcome will be assessed by noting the operator rated overall procedure satisfaction as a VAS scale score.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
5 sprays of 10% lignocaine	Drug	5 sprays of 10% lignocaine	5 sprays

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Operator rated overall procedure satisfaction	Visual Analogue Scale score (VAS) between 0 to 100	At study completion at approximately 4 months

Secondary Outcomes

Measure	Description	Time Frame
Operator rated cough	Visual Analogue score (VAS) between 0 to 100	At study completion at approximately 4 months
Time from bronchoscope introduction to reaching the vocal cords	Time in seconds

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adults ≥ 18 yrs of age undergoing flexible bronchoscopy

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Karan Madan, MD DM	Contact	00911126593488		drkaranmadan@gmail.com
Anant Mohan, MD	Contact	00911126593006		anantmohan@yahoo.com

Overall Officials

Name	Affiliation	Role
Randeep Guleria, MD DM	All India Institute of Medical Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AIIMS	Recruiting	New Delhi		110029	India

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008012	Lidocaine

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Quadruple

Masking Description

Group allocation by opaque sealed envelopes. Participant and bronchoscopist shall be unaware of the number of sprays administered.

Who Masked

ParticipantCare ProviderInvestigatorOutcomes Assessor