| CTRI Number |
CTRI/2017/03/008188 [Registered on: 23/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
25/05/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison Of Only Ketamine Nebulization And Combined Ketamine Dexmedetomidine Nebulization Before Putting Paediatric Patients Under Anaesthesia for Surgeries As to Produce Sleep And to Relieve Anxiety |
|
Scientific Title of Study
|
A Comparative Evaluation Of Nebulized Ketamine And Its Combination With Dexmedetomidine As Premedication For Paediatric Patients Undergoing Surgeries Under General Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shital Dharamkhele |
| Designation |
Junior Resident Anaesthesiology |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
Department of Anaesthesiology and Critical Care,
Armed forces Medical College ,Solapur Road,Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9545810604 |
| Fax |
|
| Email |
dharamkhele@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Col Dr Naresh Dhawan |
| Designation |
Associate Professor |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
Department Of Anaesthesiology And Critical Care,
Armed Forces Medical College,
Solapur Road,Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9158257700 |
| Fax |
|
| Email |
naresh_d59@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Col Dr Naresh Dhawan |
| Designation |
Associate Professor |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
Department Of Anaesthesiology And Critical Care,
Armed Forces Medical College,
Solapur Road,Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9158257700 |
| Fax |
|
| Email |
naresh_d59@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Armed forces Medical College,Solapur Road, Pune |
|
|
Primary Sponsor
|
| Name |
Armed forces Medical College Pune |
| Address |
Department Of Anaesthesiology and Critical Care,
Armed Forces Medical College,Solapur Road,Pune |
| 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 Shital Dharamkhele |
Armed forces Medical College Pune |
Department of Anaesthesiology and critical care
Armed forces Medical College
Solapur Road Pune
Pune
MAHARASHTRA |
9545810604
dharamkhele@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Research Cell and Institutional Ethical Committee ,Armed Forces Medical College, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Paediatric Patients undergoing surgeries under General Anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nebulised Ketamine 1mg/kg and Dexmedetomidine 1 mcg/kg Combination |
Group Y patients will be premedicated with combined ketamine(1mg/kg) and dexmedetomidine(1mcg/kg) nebulised solution |
| Intervention |
Nebulised Ketamine 2mg/kg |
Group X Patients Will Be Premedicated With Nebulized Ketamine Solution 2mg/kg |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than 3 years and less than 10 years undergoing surgeries under General Anaesthesia.
2. Paediatric patients with ASA physical status grade I or II
3.Tolerating Nebulization |
|
| ExclusionCriteria |
| Details |
1.Known allergy/Hypersensitivity to study drug
2.Congenital diseases (Congenital Heart Diseases, Down’s syndrome etc.)
3.Child with developmental delay and/or with neurological disease (Cerebral palsy, Raised ICP etc )
4.History of Chronic illness
5.known case of Bronchial Asthma
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of nebulised ketamine and its combination with dexmedetomidine on sedation level in paediatric patients.
|
30 Minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of nebulised ketamine and its combination with dexmedetomidine on facemask acceptance during induction in operation room |
30-45 Minutes |
Occurrence of any adverse events in both the study groups.
|
From the time of premedication to the induction of anaesthesia. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/03/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is the double blinded randomized controlled Study to Compare efficacy of nebulized ketamine (2mg/kg) and nebulized ketamine(1mg/kg)+dexmedetomidine(1mcg/kg) combination as a premedication on sedation level before the induction of Anaesthesia and facemask acceptance at the time of induction of anaesthesia in a paediatric patients undergoing surgeries under General Anaesthesia.
|