| CTRI Number |
CTRI/2024/01/061802 [Registered on: 24/01/2024] Trial Registered Prospectively |
| Last Modified On: |
18/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of 5% Eutectic Mixture Of Local Anaesthetics (EMLA) Cream On Sore Throat, Cough And Hoarseness Of Voice After General Anaesthesia - A Randomized Control Trial |
|
Scientific Title of Study
|
Effect Of 5% Eutectic Mixture Of Local Anaesthetics (EMLA) Cream Over Endotracheal Tube On Post Operative Sore Throat, Cough And Hoarseness Of Voice - A Randomized Control Trial |
| 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 Sandhana Inian |
| Designation |
Junior Resident |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9500828776 |
| Fax |
|
| Email |
sandhana96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Thamarai Selvi |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841552333 |
| Fax |
|
| Email |
thamarai@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandhana Inian |
| Designation |
Junior Resident |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9500828776 |
| Fax |
|
| Email |
sandhana96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Dr Sandhana Inian |
| Address |
Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai- 600116 |
| 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 Sandhana Inian |
Sri Ramachandra Institute of Higher Education and Research |
Department of Anaesthesiology, SRIHER, Porur, Chennai-600116
Chennai
TAMIL NADU |
9500828776
sandhana96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Ethics Committee(For PG Students of 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 |
Control group |
Intubation without application of any topical anaesthetic agent |
| Intervention |
EMLA group |
Application of 2 ml of 5% EMLA cream over the cuff and distal portion of endotracheal tube (outer surface) prior to intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients undergoing elective surgeries under general anaesthesia with endotracheal intubation. Expected duration of surgery is 1 to 3 hours |
|
| ExclusionCriteria |
| Details |
Known allergy to local anaesthetics, pre operative sore throat, difficult airway, more than 2 intubation attempts, use of throat pack, head and neck surgery involving airway, post operative mechanical ventilation, surgeries in prone position |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of post operative sore throat, cough and hoarseness of voice |
2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of post operative sore throat, cough and hoarseness of voice |
6 hours and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
29/01/2024 |
| Date of Study Completion (India) |
06/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This trial is being conducted to determine the incidence of post operative sore throat, cough and hoarseness of voice after the application of 5% EMLA cream over the endotracheal tube. This study will be conducted on patients of age 18-65 years undergoing surgeries of 1 to 3 hours duration under general anaesthesia with endotracheal tube. |