| CTRI Number |
CTRI/2025/07/090189 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study on 5 percentage EMLA Numbing cream helps the adult patient to reduce chance and intensity of post operative sore throat after the tube placement following general anaesthesia
|
|
Scientific Title of Study
|
Effectiveness Of 5 percentage EMLA Cream in reducing Post Operative Sore Throat in adults undergoing General Anaesthesia A prospective observational 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 |
Sandhiya M N |
| Designation |
Post graduate student |
| Affiliation |
Yenepoya school of allied health sciences |
| Address |
Department of Anaesthesia and OT Technology Yenepoya School Of Allied Health Sciences Yenepoya (deemed to be university) Deralakatte Mangalore
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9444323582 |
| Fax |
|
| Email |
dhiya3159@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr ManjulaSudhakarRao |
| Designation |
Assistant professor |
| Affiliation |
Yenepoya Medical College Hospital |
| Address |
Department of Anesthesiology, Yenepoya Medical College Hospital, Yenepoya (Deemed to be university),Deralakatte Mangalore
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9902518580 |
| Fax |
|
| Email |
Manjul.kshema@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Manjula Sudhakar Rao |
| Designation |
Assistant professor |
| Affiliation |
Yenepoya medical college hospital |
| Address |
Department of Anesthesiology, Yenepoya Medical College Hospital, Yenepoya (Deemed to be university),Deralakatte Mangalore
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9902518580 |
| Fax |
|
| Email |
Manjul.kshema@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya medical college, yenepoya (deemed to be university) Deralakatte, Mangalore, dakshina kannada, Karnataka, india 575018 |
|
|
Primary Sponsor
|
| Name |
Sandhiya M N |
| Address |
Yenepoya School Of Allied Health Science, mudipu Campus naer Surya tech park kayargoli,Kurnad post bantwal 574153 |
| 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 Manjula Sudhakar Rao |
Yenapoya medical college hospital |
Postoperative ward andOperation TheatreComplex 6th floor and3rd floor Department ofAnaesthesiologyDeralakatte Mangalore575018 DakshinaKannada KarnatakaDakshina KannadaKARNATAKA Dakshina Kannada KARNATAKA |
09902518580
Manjul.kshema@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 4 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients Undergoing elective surgery under general anesthesia with ASA PHYSICAL STATUS 1 AND 2 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA: Adult patient of aged 19 to 65 years
ASA 1 and 2 scheduled for Elective surgeries
Electives surgeries – ENT, Laparoscopic surgeries, oncology surgeries and the surgeries which required general anaesthesia
Duration of surgeries 4 to 6 hours under general with endotracheal anaesthesia |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA: Allergy to local anaesthetics
More than 2 intubation attempts
Assisted nasogastric tube inserted or the use of throat pack
The instrumentation which involve upper airway surgeries
Pre-operative sore throat
Difficult airway
Surgeries in prone position |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Percentage EMLA Cream in reducing the incidence and severity of postoperative sore throat in adult patient after general anaesthesia. |
Incidence and severity of postoperative sore throat and Hoarseness will be assessed by using a grade at four time points(after 1 hour, after 6,after 12 hours and after 24hours postoperatively) [5-6min] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine patient satisfaction comfort levels associated with the use of EMLA Cream for postoperative sore throat prevention |
Satisfaction comfort levels of the patients will be assessed in postoperative room after 1hour of the surgery |
|
|
Target Sample Size
|
Total Sample Size="46" Sample Size from India="46"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="11" 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
|
Title:Effectiveness Of 5% EMLA Cream in reducing Post Operative Sore Throat in adults undergoing General Anaesthesia - A prospective observational study
The patients who meet the inclusion criteria will be selected for this study. After obtaining approval from the ethical committee, the data will be collected. The basic parameters are collected from the patient and Mallampati and Cormack lehane grading will be assessed. Mallampati grading is a clinical assessment used to evaluate the visibility of structures in the mouth and throat to help predict the difficulty of intubation. CLASS I (full visibility of all structures), CLASS 2(Soft palate, fauces, and uvula visible), CLASS 3(Soft palate and base of uvula visible), CLASS 4(Only hard palate visible; soft palate not visible). Cormack-Lehane grading is a system used to describe the view of the larynx during direct laryngoscopy, primarily to assess the difficulty of intubation. Grade I: Full view of the glottis (vocal cords visible). Grade II: Partial view of the glottis (only posterior part visible). Grade III: Only epiglottis visible; no part of the glottis seen. Grade IV: Neither glottis nor epiglottis visible. It will be performed each time by simple random sampling method by using a computerized randomizing software.Once the patient is shifted to operation theatre. An expert anaesthesiologist with at least 3 years of experience will perform direct mild laryngoscopy and intubation within 15 seconds. Lubricating ETT with 5% EMLA Cream. After surgery, the patient will be transferred to the post-operative unit and monitored for POST at 4th, 6th, and 24th hours to assess its severity. POST refers to symptoms such as throat soreness, coughing, and hoarseness within 24 hours Post surgery. [3] POST intensity will be classified into four levels: none (grade 0), mild (grade 1-Less than a common cold), moderate (grade 2-Similar to a common cold), and severe (grade 3-More than a common cold) Grade 2 and 3 POST was considered as significant POST. Cough severity will be categorized as NO COUGH (0-no cough at any time since the operation), MILD (1-mild cough or occasional cough), MODERATE (2-similar to a common cold), and SEVERE (3-more than a common cold ). Hoarseness of voice will be classified as NO HOARSENESS (0-no evidence of hoarseness at any time after operation), MINIMAL (1-no hoarseness at the time of interview but was present previously), MODERATE (2-moderate change in quality of speech ), or SEVERE (3-recognizable at the time of interview)12. Visual analog scale is used to assess the patient satisfaction/comfort and pain. Patients will be monitored for any potential adverse effects, including allergic responses. Participants in the study who experience post-operative sore throat despite using 5% EMLA cream will be treated according to department and hospital protocols. |