| CTRI Number |
CTRI/2020/08/027485 [Registered on: 31/08/2020] Trial Registered Prospectively |
| Last Modified On: |
28/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Preoperative ketamine nebulization on attenuation of incidence and severity of post-operative sore throat, hoarseness of voice and cough |
|
Scientific Title of Study
|
Effect of Preoperative ketamine nebulization on attenuation of incidence and severity of post-operative sore throat, hoarseness of voice and cough A randomized double blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naveen Kumar Jangid |
| Designation |
P.G. Student |
| Affiliation |
J.L.N. medical college ajmer |
| Address |
Department of Anaesthesiology
JLN Medical college Ajmer Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
7014510966 |
| Fax |
|
| Email |
njangid83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Patodi |
| Designation |
Senior Professor and Guide |
| Affiliation |
J L N Medical college Ajmer |
| Address |
Department of Anaesthesiology
JLN Medical college Ajmer Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Patodi |
| Designation |
Senior Professor and Guide |
| Affiliation |
J L N Medical college, Ajmer |
| Address |
Department of Anaesthesiology
JLN Medical college Ajmer Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
JLN Medical College Ajmer Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
JLN Medical College Ajmer |
| Address |
Department of anaesthesiology jln medical college ajmer |
| Type of Sponsor |
Government 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 Naveen Kumar Jangid |
JLN Medical College |
Department of Anaesthesiology JLN Medical College Ajmer Rajasthan
Ajmer
RAJASTHAN |
7014510966
njangid83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, JLN Medical College Ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
50 mg ketamine with 4 ml normal saline and 5 ml normal saline |
compare the incidence and severity of post operative sore throat hoarseness of voice and cough |
| Intervention |
Nebulization |
Incidence and severity of post operative sore throat hoarseness of voice and cough is
assessed and duration of study
is around 1 year |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 20-60 years of either sex
Undergoing surgeries under general anaesthesia in supine position
Duration of surgery up to 2 hours
ASA physical status – I & II
|
|
| ExclusionCriteria |
| Details |
Age < 20 and >60 years
ASA physical status III & above
Mallampatti grade >2
Any psychiatric disorder and history of epilepsy
Neurosurgical patients with raised intracranial pressure
Patients with known coronary artery disease, old myocardial infarction and ischemic heart disease
Pregnancy
Patient sensitive or allergic to study drug
History of pre-operative sore throat, oral surgeries, asthma, chronic obstructive pulmonary disease, head and neck surgeries.
Recent non-steroidal drug medication
Anticipated difficult intubation
Patient and/or his/her legally acceptable representative not willing to provide their voluntary written informed consent for participation in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess incidence and severity of
Post-operative sore throat (POST)
Post-operative Hoarseness of voice
Post-operative Cough
|
Duration of study is around 1 yer |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess
Haemodynamic changes (HR, SBP, DBP, MAP &SpO2)
Side effects, if any
|
Duration of study is round 1 year |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2020 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of this study is to evaluate the role of nebulization with ketamine in attenuating the incidence and severity of Post-operative sore throat, hoarseness of voice and cough in patients undergoing various surgeries under general anaesthesia with endotracheal intubation. PRIMARY OBJECTIVES To assess incidence and severity of Post-operative sore throat (POST) Post-operative Hoarseness of voice Post-operative Cough SECONDARY OBJECTIVES Haemodynamic changes (HR, SBP, DBP, MAP &SpO2) Side effects, if any |