| CTRI Number |
CTRI/2023/12/060883 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
26/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A study of lignocaine and lubricant gel on post operative cough,sore throat and hoarseness when applied in patients undergoing general surgery during anaesthesia |
|
Scientific Title of Study
|
A comparative study of lignocaine and lubricant gel(hydroxyethyl cellulose with chlorhexidine gluconate) application over endotracheal tube on postoperative sore throat ,cough and hoarseness among patients undergoing surgery under general anaesthesia.sms hospital,jaipur(2022-24) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajeev Sharma |
| Designation |
Senior professor |
| Affiliation |
Sms medical College |
| Address |
Sms medical College
Dept of anaesthesia
Plastic surgery ot
2floor dhanvantari
Sms medical College
2 floor dhanvantari
Plastic surgery ot
Jaipur
RAJASTHAN
302012
India |
| Phone |
9829088926 |
| Fax |
|
| Email |
sharmarajeev@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Sharma |
| Designation |
Senior professor |
| Affiliation |
Sms medical College |
| Address |
Sms medical College
2 floor dhanvantari
Plastic surgery ot
Sms medical College
2 floor dhanvantari
Plastic surgery ot
Jaipur
RAJASTHAN
302012
India |
| Phone |
9829088926 |
| Fax |
|
| Email |
sharmarajeev@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepika chandra |
| Designation |
Junior resident |
| Affiliation |
Sms medical College |
| Address |
Sms medical College
2 floor dhanvantari
Plastic surgery ot
Sms medical College
2 floor dhanvantari
Plastic surgery ot
Jaipur
RAJASTHAN
302012
India |
| Phone |
09672454016 |
| Fax |
|
| Email |
deepika3chandra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sms medical College
2 floor dhanvantari
Plastic surgery ot |
|
|
Primary Sponsor
|
| Name |
sms medical College |
| Address |
Sms medical College
2 floor dhanvantari
Department of anesthesiology
Plastic surgery ot |
| Type of Sponsor |
Government medical college |
|
|
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 Rajeev Sharma |
sms medical College |
Sms medical College jaipur
2 floor dhanvantari
Plastic surgery ot
Dept of anaesthesia
Jaipur
RAJASTHAN |
9829088926
sharmarajeev@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the ethical committee SMS medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Endotracheal tube |
2 ml lubricant gel
Duration at 0,1 and 6 hour |
| Intervention |
Endotracheal tube |
2ml Lignocaine jelly
Durations at 0,1and 6 hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to give consent
Patient with grade 1 and 2 mallampatti score and mouth opening of more than 3 finger
Patient admitted for operation under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient having anticipated difficult intubation
Patient having allergy and hypersensitivity to study drug
Patient having upper respiratory tract infection
Patient requiring multiple attempts of intubation |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportional of cases with postoperative cough,sore throat & hoarseness |
0,1and6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate & blood pressure |
0 minutes of extubation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
10/01/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To assess and compare effect of lignocaine jelly and lubricant gel on post operative airway symptoms like sore throat,cough and hoarseness of voice on applying to endotracheal tube during intubation in general surgery |