| CTRI Number |
CTRI/2025/10/096072 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the effect of ketamine and dexamethasone in the tube used during surgery on throat pain, cough and voice changes after surgery |
|
Scientific Title of Study
|
A comparative observational study to assess the effect of ketamine and dexamethasone for endotracheal tube cuff inflation on post-operative sore throat, cough and hoarseness of voice |
| 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 Ruchi Shadija |
| Designation |
PG Resident |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Room no 1 Dept of Anaesthesia 1st floor Peoples Hospital PCMS and RC Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9130640288 |
| Fax |
|
| Email |
ruchishadijasatna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahima Batra |
| Designation |
Professor and Head of Department |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Room no 1 Dept of Anaesthesia 1st floor Peoples Hospital PCMS and RC Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9752075418 |
| Fax |
|
| Email |
drmahimabatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahima Batra |
| Designation |
Professor and Head of Department |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Room no 1 Dept of Anaesthesia 1st floor Peoples Hospital PCMS and RC Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9752075418 |
| Fax |
|
| Email |
drmahimabatra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples Hospital Peoples College of Medical Sciences and Research Centre Bhopal |
|
|
Primary Sponsor
|
| Name |
Peoples Hospital |
| Address |
Peoples College of Medical Sciences and Research Centre Bhanpur Bhopal Madhya Pradesh 462037 |
| Type of Sponsor |
Private medical college |
|
|
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 Ruchi Shadija |
Peoples Hospital |
Peoples College of Medical Sciences and Research Centre Bhanpur Bhopal
Bhopal
MADHYA PRADESH |
9130640288
ruchishadijasatna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL 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 |
| Comparator Agent |
Inflating endotracheal tube cuff with dexamethasone |
patients posted for elective surgery under general anaesthesia will be intubated with endotracheal tube where the cuff will be inflated with dexamethasone 0.1 mg per kg diluted in 5ml NS and will be observed for postoperative sore throat, cough and hoarseness of voice |
| Intervention |
Inflating endotracheal tube cuff with ketamine |
patients posted for elective surgery under general anaesthesia will be intubated with endotracheal tube where the cuff will be inflated with ketamine 0.4 mg per kg diluted in 5ml NS and will be observed for postoperative sore throat, cough and hoarseness of voice |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give informed consent
ASA grade I and II
Patients posted for elective surgeries under general anaesthesia with endotracheal tube intubation lasting for more than 2 hours |
|
| ExclusionCriteria |
| Details |
Patients not giving informed consent
ASA grade more than III
History of postoperative sore throat
History of asthma or chronic obstructive disease
Patients who require more than 1 attempt for intubation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of post operative sore throat cough hoarseness of voice |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
03/11/2025 |
| 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
|
Patients posted for elective surgeries under general anesthesia will be placed in 2 groups. For patients under group K the endotracheal tube cuff will be inflated with inj. ketamine 0.4 mg per kg diluted in 5ml NS and for the patients under group D the endotracheal tube cuff will be inflated with inj. dexamethsone 0.1 per kg diluted in 5ml NS. Post operatively patients will be assessed at 1,6,24 hours for post operative sore throat, cough and hoarseness of voice |