| CTRI Number |
CTRI/2020/04/024796 [Registered on: 22/04/2020] Trial Registered Prospectively |
| Last Modified On: |
14/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Is 1% lignocaine drug similar to 2% lignocaine when used in airway anaesthesia in a routine bronchoscopy procedure? |
|
Scientific Title of Study
|
Randomized controlled trial to study efficacy of 1% vs 2% lignocaine in topical airway anaesthesia in routine bronchoscopy procedures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Danny Prasad |
| Designation |
Junior Resident |
| Affiliation |
CMC,Vellore |
| Address |
Respiratory Medicine Dept
7th floor,ISSCC building
CMC Vellore
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
8427668064 |
| Fax |
|
| Email |
dannyprasad29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prince James |
| Designation |
Professor |
| Affiliation |
CMC,Vellore |
| Address |
Respiratory Medicine Dept
7th floor,ISSCC building
CMC Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9600771709 |
| Fax |
|
| Email |
drprincej@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prince James |
| Designation |
Professor |
| Affiliation |
CMC,Vellore |
| Address |
Respiratory Medicine
7th floor,ISSCC building
CMC Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9600771709 |
| Fax |
|
| Email |
drprincej@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Prince James |
| Address |
Dr Prince James
Professor
Respiratory Medicine
CMC Vellore
Vellore
Tamil Nadu-632004
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Major Danny Prasad |
Christian Medical college Vellore |
Room no.1
Bronchoscopy suite
Near K ward
Respiratory Medicine
Christian Medical college,Vellore
Vellore
TAMIL NADU |
8427668064
dannyprasad29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee,Institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1% lignocaine used as spray as you go technique |
1% lignocaine will be used for topical airway anaesthesia as a spray as you go technique in routine bronchoscopy procedure |
| Comparator Agent |
2% lignocaine used as a spray as you go technique |
2% lignocaine will be used as a spray as you technique for topical airway anaesthesia in routine bronchoscopy procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Consecutive patients undergoing flexible bronchoscopy during study period will be considered
eligible for inclusion if they are
1.Aged above 18 years
2.Hemodynamically stable(defined systolic B.P>100mmHg,<180mmHg)
|
|
| ExclusionCriteria |
| Details |
1. Failure to provide informed consent
2. Documented history of lignocaine toxicity
3. Pregnancy
4. Patients undergoing TBNA and other interventions
5. Wherein bronchoscopy was performed through endotracheal or tracheostomy tube
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the cough scores during the procedure between two study groups that is 1% lignocaine and 2% lignocaine by using VAS score(0-100mm) |
1.Immediately after procedure- Cough score as assessed by bronchoscopist,respiratory therapist and staff nurse assisting the procedure
2.Two hours after procedure-cough score as assessed by patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine overall feel of scopy as assessed by patient based on FACES pain scale score |
within 2 hours of procedure |
| To determine overall feel of scopy for the operator based on VAS score(0-100mm scale) |
immediately after the procedure |
| To determine total dose of lignocaine (in mg) used while performing procedure for 1% vs 2% concentrations |
immediately after the procedure |
| To determine overall complication rate in number while undergoing bronchoscopy procedures in 1% vs 2% lignocaine |
immediately after the procedure |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of this study is to compare the efficacy of two lignocaine strengths that is 1% and 2% in suppressing cough in patients undergoing routine brochoscopy procedures in our hospital setting.Also the study aims at comparing its effect on overall satisfaction of bronchoscopist ,with regards to conduct of the procedure as well as overall satisfaction of patient during the procedure.The optimal concentration of lignocaine to be used in flexible bronchoscopy remains unknown.This randomized controlled trial will try to compare the efficacy of 1% and 2% lignocaine solutions for topical airway anaesthesia during routine bronchoscopy.Patient s will be recruited from outpatient and inpatients under respiratory and pulmonary medicine and the study will be conducted in the bronchoscopy suite of CMC Vellore hospital.It will be conducted as a investigator,patient,outcome asessor,daty entry operator blinded RCT .The main primary outcome is cough score as rated by the operator using VAS scores |