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CTRI Number  CTRI/2025/06/089876 [Registered on: 30/06/2025] Trial Registered Prospectively
Last Modified On: 29/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   "Easing Postoperative Sore Throat:A comparison of Tranexamic Acid and Hydrocortisone"  
Scientific Title of Study   comparative evaluation of intravenous hydrocortisone and intravenous tranexamic acid for post operative sore throat in patients undergoing general anaesthesia with endotracheal intubation for elective surgeries: A double blind randomized controlled trial 
Trial Acronym  THROAT Trial [Tranexamic acid vs Hydrocortisone for Relief Of After-surgery Throat pain] 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR OM PRAKASH ADITYA 
Designation  CONSULTANT ANAESTHESIOLOGIST 
Affiliation  RAIPUR INSTITUTE OF MEDICAL SCIENCES 
Address  Department of Anaesthesia ,3rd floor operation theater hospital building Raipur Institute of Medical sciences Bhansoj road , off NH -6 Raipur

Raipur
CHHATTISGARH
492006
India 
Phone  8691025905  
Fax    
Email  adityaom2683@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR OM PRAKASH ADITYA 
Designation  CONSULTANT ANAESTHESIOLOGIST 
Affiliation  RAIPUR INSTITUTE OF MEDICAL SCIENCES 
Address  Department of Anaesthesia ,3rd floor operation theater hospital building Raipur Institute of Medical sciences Bhansoj road , off NH -6 Raipur

Raipur
CHHATTISGARH
492006
India 
Phone  8691025905  
Fax    
Email  adityaom2683@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR OM PRAKASH ADITYA 
Designation  CONSULTANT ANAESTHESIOLOGIST 
Affiliation  RAIPUR INSTITUTE OF MEDICAL SCIENCES 
Address  Department of Anaesthesia ,3rd floor operation theater hospital building Raipur Institute of Medical sciences Bhansoj road , off NH -6 Raipur

Raipur
CHHATTISGARH
492006
India 
Phone  8691025905  
Fax    
Email  adityaom2683@gmail.com  
 
Source of Monetary or Material Support  
RAIPUR INSTITUTE OF MEDICAL SCIENCES , RAIPUR 
 
Primary Sponsor  
Name  RAIPUR INSTITUTE OF MEDICAL SCIENCES 
Address  Bhansoj road Off NH-6, Raipur, Chhattisgarh 492006 
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 Om Prakash Aditya  RIMS HOSPITAL  Department of Anaesthesia ,3rd floor operation theater hospital building Raipur Institute of Medical sciences Bhansoj road , off NH -6 Raipur
Raipur
CHHATTISGARH 
8691025905

adityaom2683@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE , RAIPUR INSTITUTE OF MEDICAL SCIENCES   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  preventive intervention 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Injection hydrocortisone   after randomization patients will recieve either ijn hydrocortisone100 mg or inj tranexamic acid 1000 mg at the time of induction and will be assessed for incidence and severity of post operative sore throat at 2 hrs, 4 hrs 6 hrs 12 hrs and 24 hrs after surgery 
Intervention  injection tranexamic acid  after randomization patients will recieve either ijn hydrocortisone100 mg or inj tranexamic acid 1000 mg at the time of induction and will be assessed for incidence and severity of post operative sore throat at 2 hrs, 4 hrs 6 hrs 12 hrs and 24 hrs after surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA grade I and II
2. Age between 20 to 60 years
3. Patients undergoing surgeries under general anaesthesia with tracheal intubations
4. Surgeries lasting 1 to 3 hours
 
 
ExclusionCriteria 
Details  1. Patient refusal.
2. Patient with known allergy to drug
3. Patients with IHD, valvular heart disease.
4. Patients with history of or with risk factors for thromboembolism.
5. Patients with renal dysfunction.
6. Patients with elevated AST, ALT values.
7. Pregnant and lactating patients.
8. Patients undergoing surgeries under general anaesthesia with supraglottic airway devices.
9. Patients already taking tranexamic acid or hydrocortisone (or other steroids) for any other indication.
10. History of convulsions .
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. incidence and severity of post operative sore throat
 
2 hours
4 hours
6 hours
12 hours
24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
has sore throat affected your ability to eat or drink  2 hours
4 hours
6 hours
12hours
24 hours 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   23/07/2025 
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="1"
Months="0"
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  

Post operative sore throat is a common complication following general anesthesia and endotracheal intubation which can lead to significant discomfort in patients and delay in returning to their normal daily activities. The tracheal mucosa has been observed to release inflammatory mediators after intubation suggesting that the aetiology for postoperative sore throat is likely an inflammatory process.

Tranexamic acid is a synthetic lysine analogue that inhibits the proteolytic action of plasmin on fibrin clots and platelet receptors thereby inhibiting fibrinolysis. It is widely used to treat various diseases such as leukaemia hypermenorrhoea and haemophilia and for prevention of blood loss during surgery or acute trauma. Besides its haemostatic effect tranexamic acid is also applied in mucocutaneous diseases such as tonsillitis angioedema stomatitis and urticaria. Therefore it is sometimes prescribed with cold medicine including pharyngitis in Japan.

Tranexamic acid is a synthetic lysine analogue that inhibits the proteolytic action of plasmin on fibrin clots and platelet receptors thereby inhibiting fibrinolysis. It is widely used to treat various diseases such as leukaemia hypermenorrhoea and haemophilia and for prevention of blood loss during surgery or acute trauma. Besides its haemostatic effect tranexamic acid is also applied in mucocutaneous diseases such as tonsillitis angioedema stomatitis and urticaria. Therefore it is sometimes prescribed with cold medicine including pharyngitis in Japan.

 In a recent study done by Okholm et al. they have found that tranexamic acid might modulate the inflammatory response by enhancing or inhibiting the levels of cytokines.in their study they found that anti inflammatory effect of TXA was consistent in orthopaedic patients however they found no inflammatory effect of TXA in patients undergoing cardiac or paediatric surgeries.

  Corticosteroids are known for their potent anti inflammatory effects whatever the source of the inflammation is i.e. infection chemical or physical damage or immune deficiency36 hence it was hypothesized that anti inflammatory characteristics of hydrocortisone may prevent postoperative sore throat or decrease its severity.] However in a study conducted by Eydi M et al. they found no effect of intravenous hydrocortisone on incidence and severity of post operative sore throat. In another study done by Bergeson K et al. they concluded that use of single dose of corticosteroid can alleviate pain and even decrease the requirement of antibiotics in patients suffering from severe or exudative sore throat.

  In present study we want to compare the effect of intravenous hydrocortisone and intravenous tranexamic acid on incidence and severity of postoperative sore throat in patients undergoing general anaesthesia with endotracheal intubation for elective surgeries.

 

 
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