| CTRI Number |
CTRI/2021/07/035146 [Registered on: 27/07/2021] Trial Registered Prospectively |
| Last Modified On: |
26/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of dexamethasone nebulization on attenuation of sore throat, hoarseness of voice and cough in general anaesthesia. |
|
Scientific Title of Study
|
Effect of Preoperative dexamethasone nebulization for attenuation of postoperative sore throat, hoarseness of voice and cough in general anaesthesia: A randomized controlled double blinded 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 Nupur Jolly |
| Designation |
Post Graduate Student |
| Affiliation |
JLN Medical College , Ajmer |
| Address |
Department of Anaesthesia, JLN Medical College and Attached Hospitals, Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9460500300 |
| Fax |
|
| Email |
jolly0750@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Jain |
| Designation |
Senior Professor |
| Affiliation |
JLN Medical College, Ajmer |
| Address |
Department of Anaesthesia, JLN Medical College and Attached Hospitals, Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414006151 |
| Fax |
|
| Email |
drkavitajain15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Jain |
| Designation |
Senior Professor |
| Affiliation |
JLN Medical College, Ajmer |
| Address |
Department of Anaesthesia, JLN Medical College and Attached Hospitals, Ajmer
RAJASTHAN
305001
India |
| Phone |
9414006151 |
| Fax |
|
| Email |
drkavitajain15@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JLN Medical College Ajmer |
| Address |
Department of Anaesthesia, JLN Medical College and Attached Hospitals, 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 Kavita Jain |
JLN Medical College Ajmer |
Department of Anaesthesia, JLN Medical College and Attached Hospitals, Ajmer
Ajmer
RAJASTHAN |
9414006151
drkavitajain15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, JLN Medical College |
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 |
Nebulisation with Normal Saline. |
Nebulization with normal saline alone, total volume 5ml, in pediatric patients undergoing various surgeries under general anaesthesia with endotracheal intubation.
Once for 15minutes before intubation
|
| Intervention |
Nebulization with Dexamethasone and Normal Saline |
Nebulization with dexamethasone 0.16mg/kg and normal saline total volume 5ml, in pediatric patients undergoing various surgeries under general anaesthesia with endotracheal intubation.
Once for 15minuters before intubation
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 6-14 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 < 6and >14 years
ASA physical status III and above
Mallampati grade > 2
Any psychiatric disorder or history of epilepsy
Neurosurgical patients with raised intracranial pressure
Patients with cardiac anomalies
Patients 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
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the incidence and severity of-
Postoperative sore throat (POST)
Postoperative Hoarseness of voice
Post-operative Cough |
0hr,2hr,4hr,6hr,12hr,24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haemodynamic parameters (HR, SBP, DBP, MAP & SpO2)
Side effects, if any |
0hr,2hr,4hr,6hr,12hr,24hr |
|
|
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)
|
20/08/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sore throat, hoarseness of voice and cough are common postoperative complications following endotracheal intubation, and are more commonly found in the pediatric population. These problems, although self limiting, lead to patient’s discomfort. Postoperative sore throat along with hoarseness of voice and cough contributes to postoperative morbidity and patient dissatisfaction. Post-operative sore throat has been rated by patients as the eighth most adverse effect in the postoperative period.
Dexamethasone is a corticosteroid which has been used here owing to its anti-inflammatory and membrane-stabilizing action. Its onset for action is 1 hour after administration. It is used in the treatment of many inflammatory and auto-immune diseases such as rheumatoid arthritis, severe allergies, asthma, chronic obstructive lung disease and ocular pains due to ophthalmic surgeries. It has been used for nebulization for attenuation of postoperative sore throat due to its anti inflammatory action.
It will be used in our study in the dose of 0.16 mg/kg with the total volume made up to 5ml using saline for prevention of postoperative sore throat. |