| CTRI Number |
CTRI/2019/03/018131 [Registered on: 15/03/2019] Trial Registered Prospectively |
| Last Modified On: |
08/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of blood pressure and heart rate with Propofol versus Ketofol in patients of head trauma undergoing surgery in General anaesthesia |
|
Scientific Title of Study
|
Comparison of haemodynamic profile of ketamine and propofol (kETOFOL) with Propofol in traumatic brain injury patients undergoing 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 |
NEHA MAHESHWARI |
| Designation |
SENIOR RESIDENT |
| Affiliation |
PGIMER |
| Address |
Senior Resident
Department of Anaesthesia and Intensive Care
Post graduate institute of Medical education and research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9451110512 |
| Fax |
|
| Email |
nehadoc2705@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Panda |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Dr Nidhi Panda.
Prof and Head of division of Neuroanaesthesia
Department of Anaesthesia.
PGIMER, sector 12, Chandigarh
SECTOR 12
CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009525 |
| Fax |
|
| Email |
nidhibp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NEHA MAHESHWARI |
| Designation |
SENIOR RESIDENT |
| Affiliation |
PGIMER |
| Address |
Department Of Anaesthesia
PGIMER
sec 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9451110512 |
| Fax |
|
| Email |
nehadoc2705@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nehru HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA
Post graduate medical education and research.
CGANDIGARH |
| Type of Sponsor |
Research institution and hospital |
|
|
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 NEHA MAHESHWARI |
PGIMER |
Department of Anaesthesia and Intensive care
Operation theatres
Chandigarh
CHANDIGARH |
7985025569
NEHADOC2705@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| pgimer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S060||Concussion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
drugs used are propofol alone and along with ketamine |
in patients with traumatic brain injury
Dose of propofol - 0.6- 0.9 ml/kg/hr
route is intravenous
Duration is intraoperative time period ( 2-3 hours approximately) |
| Comparator Agent |
propofol with ketamine and propofol combination |
Dose is 0.6ml/kg/hr (4.5mg/kg/hr propofol +1.5 mg/kg/hour ketamine) to 0.9 ml/kg/hr ( 6.75 mg/kg/hr propofol +2.25 mg/kg/hr ketamine) intravenously for intraoperative (2 to 3 hours) time period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients with moderate to severe head injury |
|
| ExclusionCriteria |
| Details |
CAD, pregnant patients..
pAtient allergic to any drug |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic Variables |
Mean Arterial Pressure,
heart rate |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ICP, Brain relaxation, plasma biomarkers |
AT 1 AND 3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
18/03/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
In the present study we aim to assess and compare the effects of ketofol with propofol alone used as an induction and maintenance agent in patients undergoing surgery for traumatic brain injury.. |