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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
 
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