| CTRI Number |
CTRI/2024/02/062885 [Registered on: 20/02/2024] Trial Registered Prospectively |
| Last Modified On: |
19/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Alkalinized lidocaine 2% and air to be given in cuff of Endo tracheal Tube on coughing during emergence from general Anesthesia and postoperative sore throat: a randomized control study. |
|
Scientific Title of Study
|
Comparison of intra cuff Alkalinized lidocaine 2% and air on coughing during emergence from general Anesthesia and postoperative sore throat: a randomized control study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shyamli Warfade |
| Designation |
Junior Resident |
| Affiliation |
Mahatma Gandhi Institute Of Medical Sciences |
| Address |
Department of Anaesthesia, Main OT Complex, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, Maharashtra 442102
Wardha
MAHARASHTRA
442001
India |
| Phone |
9822795344 |
| Fax |
|
| Email |
shyamliwarfade@mgims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sucheta Tidke |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Institute Of Medical Sciences |
| Address |
Department of Anaesthesia, Kasturba Hospital
Wardha
MAHARASHTRA
442102
India |
| Phone |
9850510019 |
| Fax |
|
| Email |
suchetatidke@mgims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sucheta Tidke |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Institute Of Medical Sciences |
| Address |
Department of Anaesthesia, Kasturba Hospital
Wardha
MAHARASHTRA
442102
India |
| Phone |
9850510019 |
| Fax |
|
| Email |
suchetatidke@mgims.ac.in |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Institute Of Medical Sciences, Sevagram, Wardha, Maharashtra 442102 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Institute Of Medical Sciences |
| Address |
Mahatma Gandhi Institute of Medical Sciences,Sevagram, Wardha, Maharashtra 442102 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shyamli Warfade |
Kasturba Hospital |
Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, Maharashtra 442102
Wardha
MAHARASHTRA |
9822795344
shyamliwarfade@mgims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee, MGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H653||Chronic mucoid otitis media, (2) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (3) ICD-10 Condition: N200||Calculus of kidney, (4) ICD-10 Condition: K811||Chronic cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intra cuff Air |
Single dose of 5 to 10 cc intra cuff Air will be given immediately after intubation while insufflating the cuff of endotracheal tube in cases of general anaesthesia |
| Intervention |
Intra cuff alkalinized 2% lidocaine |
Single dose of 5 to 10 cc Intra cuff alkalinized 2% lidocaine will be given immediately after intubation while insufflating the cuff of endotracheal tube in general anaesthesia cases |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Patient of either sex of ASA grade 1 and 2
• Age between 18-60 year
• Elective surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
• Patient of ASA grade 3 and above
• Age more than 60 years and less than 18 years
• Pregnant females
• Any cardiovascular disease, respiratory disease, Diabetes
mellitus and central nervous system diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
use of intra cuff alkalinized lidocaine 2% during general
anaesthesia decrease the incidence of coughing during emergence
and postoperative sore throat from general anaesthesia |
post extubation immediately, 30 minutes, 3 hours , 8 hours and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| If cough and post operative throat pain are present then to check upto what extent.. |
post extubation immediately, 30 minutes, 3 hours , 8 hours and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
29/02/2024 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shyamliwarfade@mgims.ac.in].
- For how long will this data be available start date provided 15-01-2024 and end date provided 15-01-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Lidocaine due to its local anaesthetic property when administered as a cuff inflation medium after endotracheal intubation of a cuffed tube, may protect the tracheal mucosa from irritant effect of the ETT through its continuous topical anaesthetic effect. Lignocaine when alkalinised has an advantage over its non alkalinised variety, with a quicker onset, duration, quality of the block. The present study is to compare intracuff alkalinised lidocaine 2% and air on coughing during emergence from general Anaesthesia and post operative sore throat |