| CTRI Number |
CTRI/2026/04/107302 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
31/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two inhaled medicines (Dexmedetomidine and Ketamine) to reduce throat discomfort after placement of a breathing tube during surgery |
|
Scientific Title of Study
|
A Comparative evaluation of Dexmedetomidine and Ketamine nebulization in preventing postoperative sore throat following endotracheal intubation |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devashri Vasudevan |
| Designation |
Anaesthesia Resident |
| Affiliation |
SKS Hospital and Post Graduate Medical Institiute |
| Address |
Department of Anaesthesiology
SKS Hospital and Post graduate Medical Institute
SKS Hospital Road
Alagapuram
Salem-636004
Dharmapuri
TAMIL NADU
635202
India |
| Phone |
09443735207 |
| Fax |
|
| Email |
devashrivasu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Prabu Gunasekaran |
| Designation |
Anaesthesiologist |
| Affiliation |
SKS Hospital and Post Graduate Medical Institiute |
| Address |
Department of Anaesthesiology
SKS Hospital and Post graduate Medical Institute
SKS Hospital Road
Alagapuram
Salem-636004
Salem
TAMIL NADU
636 004
India |
| Phone |
9884469456 |
| Fax |
|
| Email |
gprabu_mmc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Devashri Vasudevan |
| Designation |
Anaesthesia Resident |
| Affiliation |
SKS Hospital and Post Graduate Medical Institiute |
| Address |
Department of Anaesthesiology
SKS Hospital and Post graduate Medical Institute
SKS Hospital Road
Alagapuram
Salem-636004
Dharmapuri
TAMIL NADU
635202
India |
| Phone |
09443735207 |
| Fax |
|
| Email |
devashrivasu@gmail.com |
|
|
Source of Monetary or Material Support
|
| SKS Hospital and Postgraduate Medical Institue
Salem-636 004
Tamil Nadu
India |
|
|
Primary Sponsor
|
| Name |
Dr Suresh Vishwanathan |
| Address |
Managing director
SKS Hospital
23 SKS Hospital Road
Alagapuram
Salem-636 004 |
| 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 Prabu Gunasekaran |
SKS Hospital and Post Graduate Medical Institute |
Department of Anaesthesia
second floor
Salem
TAMIL NADU |
9884469456
gprabu_mmc@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKS HOSPITAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
50mcg with 4ml normal saline nebulisation over 20 minutes |
| Comparator Agent |
Ketamine |
50mg with 4ml normal saline nebulisation over 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I to III patients undergoing general anaesthesia |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of postoperative sore throat |
0, 2, 4, 8, 12 and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| 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) |
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(POST) is a common occurrence following general anesthesia with endotracheal intubation. Incidence of POST is estimated to be 21%-65% in different studies. Irritation and inflammation of the airway are considered to be the causes of POST. Although considered as a minor complication, it may cause significant patient morbidity, dissatisfaction, and increased the length of hospital stay. Nowadays, aerosolised drugs are better accepted and tolerated by the patients than gargle, as it spares them from the bitter taste of the drug. DEXMEDETOMIDINE is a colorless, tasteless and odorless drug with a selective alpha 2 adrenergic agonistic action, which causes sedation and analgesia. KETAMINE is an N-methyl-D-aspartate(NMDA) receptor antagonist has anti-nociceptive and anti-inflammatory properties. To compare the efficacy of preoperative DEXMEDETOMIDINE and KETAMINE nebulization in preventing sore throat following endotracheal intubation
|