| CTRI Number |
CTRI/2021/11/038112 [Registered on: 17/11/2021] Trial Registered Prospectively |
| Last Modified On: |
16/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of combination of sedatives(Propofol and ketamine vs Propofol and Fentanyl) in patients on ventilator |
|
Scientific Title of Study
|
Comparison of dose of Propofol when used in combination with ketamine versus Fentanyl for sedation and anti inflammatory effects in mechanically ventilated patients A double blind randomised controlled 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 Nikhil Kothari |
| Designation |
Additional professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Anesthesiology and critical care, Division of critical care,Room no:3134, AIIMS college building,
Residential complex, AIIMS, Basni phase 2, Jodhpur, Rajasthan, India,
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996948 |
| Fax |
|
| Email |
drnikhilkothari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikhil Kothari |
| Designation |
Additional professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Anesthesiology and critical care,
Division of critical care, Room No:3134,AIIMS College building,
Residential complex, AIIMS, Basni phase 2, Jodhpur, Rajasthan, India,
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996948 |
| Fax |
|
| Email |
drnikhilkothari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venkatachalam K |
| Designation |
Post doctorate student |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Anesthesiology and critical care,
Division of critical care,
Room No:SRD AICU Third floor,IP building,
AIIMS, Basni phase 2, Jodhpur,
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9944561826 |
| Fax |
|
| Email |
venkatachalamneigrihms@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Jodhpur, Research section, First floor,College building, Basni phase 2,Jodhpur, Rajasthan-342005. |
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
AIIMS, Basni phase 2, Jodhpur, Rajasthan, India, PIN 342005 |
| 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 Venkatachalam K |
AICU, AIIMS Jodhpur, |
Department of Anesthesiology and critical care, Division of critical care,Room:AICU Third floor,IP building,AIIMS, Basni phase 2, Jodhpur, Rajasthan, India
Jodhpur
RAJASTHAN |
9944561826
VENKATACHALAMNEIGRIHMS@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Jodhpur Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J952||Acute pulmonary insufficiency following nonthoracic surgery, (2) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, (3) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl |
1 mcg per kg per hour |
| Intervention |
Ketamine |
0.12 mg per kg per hour for 24 hours and 0.06 mg per kg per hour for next 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All ICU patients between 18 to 80 years who are expected to be on mechanical ventilation for more than 48 hours |
|
| ExclusionCriteria |
| Details |
1) Patients weaned of mechanical ventilation within 48 hrs of mechanical ventilation
2) Patients who are on non invasive mode of ventilation
3) Patients who had cardiac arrest and received CPR within 48 hrs of mechanical ventilation
4) Patients having history of dementia, Psychiatric disorder, on antipsychotic or antidepressants prior to ICU admission
5) Pregnant females and patients having known hypersensitivity to any of the sedative agents
6) Cardiogenic shock, Acute decompensated heart failure, MI
7) Patients having end stage liver failure ( Child Pugh C)
8) Primary neurological injury (TBI, Stroke, SCI, Anoxic brain injury, Brain edema)
9) Hemodynamically unstable patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the dose of Propofol required to achieve a target sedation score ( RASS of 0 to -2) when used in combination with Ketamine versus Fentanyl |
At Baseline, 24 Hours, 48 Hours after sedation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To compare the residual effect on sedation fue to Ketamine versus Fentanyl on stopping the infusion after 72 hours
2) To compare the anti inflammatory effects of Propofol and Ketamine versus Propofol and Fentanyl by measuring serum TNF alfa and IL 6 levels
3) To compare the dose of injection Noradrenaline required to achieve MAP more than or equal to 65 mmhg with each combination of sedative agents |
48 hours |
|
|
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)
|
01/12/2021 |
| 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="6"
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
|
Comparison of the dose of Propofol when used in combination with Ketamine versus Fentanyl for sedation and anti inflammatory effects in mechanically ventilated adult patients A double blind randomised controlled study. Purpose of trial: To find out optimal sedatives and dose in ICU and to know whether Ketamine better than Fentanyl .
|