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CTRI Number  CTRI/2025/05/087382 [Registered on: 22/05/2025] Trial Registered Prospectively
Last Modified On: 21/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A study in adult surgical patients to find out what causes sore throat after surgery and whether keeping breathing tube pressure at safe levels can help reduce it. 
Scientific Title of Study   A single-centre, prospective, two-arm, observational study to investigate the causative factors of postoperative sore throat (POST) and assess whether maintaining endotracheal tube cuff pressure between 20-30 cm H2O and supraglottic airway device cuff pressure up to 60 cm H2O influences the incidence of POST. 
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 Shilpa Tiwaskar 
Designation  Consultant Anaesthesiologist 
Affiliation  Bhaktivedanta Hospital and Research Institute  
Address  Opd No. 01, 2nd Floor, B wing , Department of Anaesthesia, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra India 401107

Thane
MAHARASHTRA
401107
India 
Phone  9820067137  
Fax    
Email  drtiwaskar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shilpa Tiwaskar 
Designation  Consultant Anaesthesiologist 
Affiliation  Bhaktivedanta Hospital and Research Institute  
Address  Opd No. 01, 2nd Floor, B wing , Department of Anaesthesia, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra India 401107

Thane
MAHARASHTRA
401107
India 
Phone  9820067137  
Fax    
Email  drtiwaskar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shilpa Tiwaskar 
Designation  Consultant Anaesthesiologist 
Affiliation  Bhaktivedanta Hospital and Research Institute  
Address  Opd No. 01, 2nd Floor, B wing , Department of Anaesthesia, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra India 401107

Thane
MAHARASHTRA
401107
India 
Phone  9820067137  
Fax    
Email  drtiwaskar@gmail.com  
 
Source of Monetary or Material Support  
Bhaktivedanta Hospital and Research Institute, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East,Thane, Maharashtra, India 401107 
 
Primary Sponsor  
Name  Bhaktivedanta Hospital and Research Institute 
Address  Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East,Thane, Maharashtra, India 401107 
Type of Sponsor  Research institution and hospital 
 
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 Shilpa Tiwaskar  Bhaktivedanta Hospital and Research Institute   Opd No. 01, 2nd Floor, B wing , Department of Anaesthesia, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra India 401107
Thane
MAHARASHTRA 		 9820067137

drtiwaskar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaktivedanta Hospital Ethics Committee for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R070||Pain in throat,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cuff inflation  Standard clinical practice without active cuff pressure monitoring. Cuff inflation: Managed using conventional techniques.  
Intervention  Endotracheal tube cuff pressure and Supraglottic airway device cuff pressure   Patients undergoing continuous monitoring of cuff pressure.Endotracheal tube cuff pressure: Maintained between 20-30 cm H2O. and Supraglottic airway device cuff pressure: Maintained up to 60 cm H2O. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. All patients of all genders above 18 years of age
2. Patients who are schedule for surgery and require general anaesthesia with use of either endotracheal tube or supraglottic airway device.
3. All ASA Grade 1 and ASA Grade 2 patients included. (ASA= American Association of Anaesthesiologists)
 
 
ExclusionCriteria 
Details  1. Patient with pre-existing sore throat due to vocal cord polyp or vocal cord growth or oral-throat cancerous growth / thyroid swelling/ tonsillitis/ no reason
2. Patients undergoing following surgeries, not be included- Micro-laryngoscopy or DL scopies for vocal cord polyp or growth and Oral-Throat cancer surgeries
3. Drowsy patient / Patients with poor General Condition/ Mentally challenged were excluded
4. Patients who required postoperative ventilator or who were shifted on T-piece excluded.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A comparison of postoperative sore throat (POST) incidence between Group A, where cuff pressure is actively monitored, and Group B, which follows standard practice without cuff pressure monitoring.  within 24 hours and at the time of discharge 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the relationship between key perioperative variables (such as intubation time, tube size, and anesthesia management) and the occurrence of postoperative sore throat (POST) in both groups.  after one year 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   04/06/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Postoperative sore throat (POST) is a common complication after general anaesthesia, often due to mucosal injury from airway devices, leading to discomfort and delayed recovery. This study aims to evaluate the relationship between perioperative factors and POST, and whether maintaining endotracheal tube cuff pressures between 20–30 cm H2O and supraglottic airway device pressures up to 60 cm H2O reduces its incidence. Adult patients over 18 years undergoing surgeries under general anaesthesia with ASA Grade 1 or 2 status will be included, while those with pre-existing throat conditions, undergoing specific throat surgeries, or requiring postoperative ventilation will be excluded. Patients will be divided into two groups: one with continuous cuff pressure monitoring and one with standard practice. The study will record demographics, medical history, anaesthesia details, and postoperative outcomes over one year with a total sample size of 50 patients. The primary endpoint is to compare the incidence of POST between the two groups, and the secondary endpoint is to assess the influence of perioperative variables on POST occurrence.


 
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