| CTRI Number |
CTRI/2025/07/091219 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on whether ketamine-soaked throat packs help reduce sore throat after nasal surgeries compared to saline-soaked throat packs. |
|
Scientific Title of Study
|
A Comparative Study on Efficacy of Ketamine Soaked Throat Pack with Saline Soaked Throat Pack on Incidence and Severity of Post Operative Sore Throat in Patients Undergoing Nasal Surgeries. |
| 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 Adharsh Gopi |
| Designation |
Junior Resident |
| Affiliation |
Amala Institute of Medical Sciences, Thrissur |
| Address |
SMRA 309B, Dharshana
Vishnathukaavu, Thirumullavaram P.O, Kollam, Kerala
Thrissur
KERALA
691012
India |
| Phone |
8943086793 |
| Fax |
|
| Email |
adharsh.gopi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajagopal P |
| Designation |
Associate Professor and Guide |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Amala Institute of Medical Sciences, Amalanagar, Thrissur, Kerala
Thrissur
KERALA
680555
India |
| Phone |
9995555239 |
| Fax |
|
| Email |
rajagopaltall@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Julie P Baby |
| Designation |
Assistant Professor and Co-guide |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Amala Institute of Medical Sciences, Amalanagar, Thrissur, Kerala
Thrissur
KERALA
680555
India |
| Phone |
9995712400 |
| Fax |
|
| Email |
julieboban451@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amala Institute of Medical Sciences, Thrissur |
|
|
Primary Sponsor
|
| Name |
Dr Adharsh Gopi |
| Address |
Junior Resident, Department of Anesthesiology, Amala Institue of Medical Sciences, Thrissur, Kerala. |
| 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 Adharsh Gopi |
Amala Institute of Medical Sciences, Thrissur |
Department of Anesthesiology, Amala Institue of Medical Sciences, Amalanagar, Thrissur, Kerala.
Thrissur
KERALA |
8943086793
adharsh.gopi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Amala Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with American Society of Anaesthesiologists (ASA) grades of I and II.
2. Patients undergoing elective nasal surgery under general anaesthesia requiring endotracheal intubation.
3. Patients with Mallampatti Grades of I and II
|
|
| ExclusionCriteria |
| Details |
1. Patients with a history of drug allergy to any of the studied drugs
2. Patients with difficulty in communication and pregnancy
3. Patients who required more than three attempts for tracheal intubation.
4. Patients with history of recent respiratory tract infection or sore throat anticipated difficult airway
5. Patients who are smokers.
6. Patients with pre-operative use of opioids and steroids.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of ketamine soaked vs saline soaked throat pack in attenuation of incidence and severity of post-operative sore throat in patients after nasal surgeries. |
0hr, 1hr, 2hr, 4hr, and 24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of ketamine soaked throat pack vs saline soaked throat pack for the prevention of post-extubation cough.
|
After extubation, post extubation cough will be graded based Harding and McVey score |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
29/07/2025 |
| 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="6"
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
|
This is a randomized, parallel-group, placebo-controlled trial comparing ketamine-soaked throat packs with saline-soaked packs in reducing post-operative sore throat (POST) in patients undergoing elective nasal surgeries under general anaesthesia. 116 ASA I–II patients aged 18–65 will be randomized into two groups. POST severity will be assessed at 0h, 1h, 2h, 4h and 24h using a 4-point scale. Post-extubation cough will also be evaluated. The study aims to assess the topical analgesic effect of ketamine in reducing sore throat and improving post-operative comfort. |