| CTRI Number |
CTRI/2023/09/057745 [Registered on: 15/09/2023] Trial Registered Prospectively |
| Last Modified On: |
26/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A comparative study to evaluate the effect of 5% Eutectic mixture of local anaesthesia(EMLA) cream vs lubricating gel on postoperative sore throat in adults following endotracheal intubation in surgeries performed under general anaesthesia |
|
Scientific Title of Study
|
An interventional randomized comparative study to evaluate the effect of 5% EMLA cream vs lubricating gel on postoperative sore throat in adults following endotracheal intubation under general anaesthesia in Department of Anaesthesia SMS Medical college, Jaipur |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohan Garg |
| Designation |
Junior Resident |
| Affiliation |
Sawai Man Singh medical college, Jaipur |
| Address |
department of anaesthesia
sms medical college, jaipur
rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
7888687806 |
| Fax |
|
| Email |
rgarg2305@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahipal Singh |
| Designation |
associate professor |
| Affiliation |
Sawai Man Singh medical college, Jaipur |
| Address |
Department of anaesthesia
sms medical college, jaipur
rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
8696909181 |
| Fax |
|
| Email |
mdhaka81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohan Garg |
| Designation |
Junior Resident |
| Affiliation |
Sawai Man Singh medical college, Jaipur |
| Address |
department of anaesthesia
sms medical college, jaipur
rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
7888687806 |
| Fax |
|
| Email |
rgarg2305@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of anaesthesiology
sms medical college, jaipur |
|
|
Primary Sponsor
|
| Name |
Depatment of Anaesthesiology |
| Address |
Sawai Man Singh medical college,Jaipur |
| 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 Rohan Garg |
sawai man singh medial college jaipur |
department of anaesthesia
sms medical college jaipur
Jaipur
RAJASTHAN |
7888687806
rgarg2305@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS medical college ethics committee |
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 |
| Intervention |
5%EMLA cream |
role of 5% Eutetic mixture of local anaesthesia (EMLA) cream applied on cuff of endotracheal tube in preventing post op sore throat in patient undergoing tracheal intubation under general anaesthesia in surgeries with estimated duration of 1-2 hours |
| Comparator Agent |
lubricant jelly |
water based lubricant jelly as placebo |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients scheduled for elective surgeries
2.Expected duration of surgery around 2 to 3 hours under general endotracheal anaesthesia
3.Patients belonging to American Society Of Anaesthesiologists (ASA) grade I, II
|
|
| ExclusionCriteria |
| Details |
1.Patients allergic to local anaesthetics
2.>2 intubation attempts, assisted nasogastric tube insertion, difficult airway
3.Patients with head and neck surgery involving airway
4.Patients with preoperative sore throat
5.Expected prolonged surgical duration (>3 hours)
6.Postoperative mechanical ventilation
7.Surgeries in prone position
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 incidence of postoperative sore throat(POST)
2 severity of POST
3 incidence and severity of post-operative cough
4 Incidence and severity of post-operative hoarseness of voice |
immediately after the surgery
2 hours post operatively
6 hours post operatively
12 hours post operatively
24 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
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)
|
07/09/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
In this randomized, placebo-controlled study, adult
patients of 18 to 50 years old, in American Society of Anesthesiologists (ASA) physical
status I and II, and of either sex will be scheduled to receive 5% EMLA cream (intervention
arm) or lubricant gel (placebo-controlled arm) applied over the ETT cuff. A postoperative sore
throat will be graded as none (0), mild (1), moderate (2), or severe(3). A
score of ≥2 will be considered as significant POST. The
incidence of POST at the sixth at 0, second, and 24 hours will be recorded, and
the incidence of significant POST (score ≥2) will also
be noted. The incidence and severity of postoperative cough and hoarseness of
voice will be recorded simultaneously. |