| 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
|
|
|
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
|
|
|
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. |