| CTRI Number |
CTRI/2025/04/085026 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
17/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation and comparison of ketamine-dexmedetomidine versus ketamine-propofol in post operative mechanically ventilated patients |
|
Scientific Title of Study
|
A Study to compare safety and efficacy of ketamine-dexmedetomidine versus ketamine-propofol in post operative mechanically ventilated patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monica Chhikara |
| Designation |
Associate professor |
| Affiliation |
Department of Anaesthesiology and Critical care |
| Address |
Room no:26, Department of anesthesia, modular ICU complex, Pt B D Sharma PGIMS,
Rohtak
Room no:26, Department of anesthesia, modular ICU complex, Pt B D Sharma PGIMS,
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9468465746 |
| Fax |
|
| Email |
chhikara.monica@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monica Chhikara |
| Designation |
Associate professor |
| Affiliation |
Department of Anaesthesiology and Critical care |
| Address |
Room no:26, Department of anesthesia, modular ICU complex, Pt B D Sharma PGIMS,
Rohtak
Room no:26, Department of anesthesia, modular ICU complex, Pt B D Sharma PGIMS,
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9468465746 |
| Fax |
|
| Email |
chhikara.monica@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vignesh P |
| Designation |
Junior Resident |
| Affiliation |
Department of Anaesthesiology and Critical care |
| Address |
Room no:26, Department of anesthesia, modular ICU complex, Pt B D Sharma PGIMS,
Rohtak
Room no:26, Department of anesthesia, modular ICU complex, Pt B D Sharma PGIMS,
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9500201876 |
| Fax |
|
| Email |
vgnsh111997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology,pt B D Sharma PGIMS,Rohtak,haryana,124001 |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma PGIMS |
| Address |
Department of Anaesthesia and Critical care, Pt B D Sharma PGIMS, Rohtak, Haryana |
| 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 |
| Drvignesh P |
pt B D Sharma PGIMS Rohtak |
Department of Anaesthesia and Critical care, Pt B D Sharma PGIMS, Rohtak, Haryana
Rohtak
HARYANA |
9500201876
vgnsh111997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee BD Sharma PGIMS,Rohtak |
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 |
| Intervention |
continuous intravenous sedation in post operative mechanically ventilated patients with ketamine dexmedetomidine combination |
Post operative patients shifted to ICU for elective mechanical ventilation for 24 to 48 hours patients comparable in terms of etiology of ICU admission and characteristics at entry to ICU will be considered for this study. Written and informed consent will be obtained from the attendants after explaining in detail about the study. Patients received in ICU will be managed as per ICU protocol. Patients will be put on assist controlled or spontaneous mode on ventilation with endotracheal tube as interface. Along with other treatment, all patients will be standardized in terms of analgesia used. Patients will receive inj. Tramadol 2mg/kg for analgesia and Inj.paracetamol 15mg/kg will be used as rescue analgesic, if needed. For sedation, all patients will get bolus dose of 1mg/kg ketamine followed by 0.25mg/kg/hour of continuous intravenous infusion. Along with ketamine infusion, dexmedetomidine infusion at 0.5 to 0.7 mcg/kg/hour will be started |
| Comparator Agent |
Continuous intravenous sedation in post operative mechanically ventilated patients with ketamine-propofol combination |
Post operative patients shifted to ICU for elective mechanical ventilation for 24 to 48 hours patients comparable in terms of etiology of ICU admission and characteristics at entry to ICU will be considered for this study. Written and informed consent will be obtained from the attendants after explaining in detail about the study. Patients received in ICU will be managed as per ICU protocol. Patients will be put on assist controlled or spontaneous mode on ventilation with endotracheal tube as interface. Along with other treatment, all patients will be standardized in terms of analgesia used. Patients will receive inj. Tramadol 2mg/kg for analgesia and Inj.paracetamol 15mg/kg will be used as rescue analgesic, if needed. For sedation, all patients will get bolus dose of 1mg/kg ketamine followed by 0.25mg/kg/hour of continuous intravenous infusion. Along with ketamine infusion this group will receive propofol infusion at 25 to 50 mcg/kg/min. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Post operative patients between 18-60 years of age, intubated and shifted to ICU for a period of 12 to 24 hours
2)Afebrile
3)Hemodynamically stable
|
|
| ExclusionCriteria |
| Details |
1)Pateint less than 18 years of age
2)patient with hypotension, Bradycardia, metabolic acidosis.
3)patients with head injury
4)patients requiring neuromascular blocking agents along with sedation
5)pregnancy
6)neurological disease or injury
7)liver or renal insufficiency
8)intraoperative or post operative hemodynamic instability
9)patients on vasopressor or ionotropic support
10)patients with metabolic derangements
11)patients receiving epidural or any other type of analgesia apart from the standardized analgesia used in study
|
|
|
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 |
1)modified RASS score
2)Nonverbal pain score
3)adverse effects |
1)Modified RASS score will be assessed at starting of infusion(0hr),1Hr,6Hr,12hr and 24hrly
2)nonverbal pain score will be assessed at starting of infusion(0hr),1hr,6hr,12hr and 24hr
3)adverse effects will be assessed at any time during continuous intravenous infusion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Recovery time
2)duration of weaning |
R time of stopping of infusion [T1] to time of return of full consciousness[T2] is recovery time will be assessed after stopping of infusion.
2)duration of weaning is that Time of start of spontaneous breathing trial[T3] to time of extubation [T4] |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
10/05/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sedative agent used in critical care unit(ICU) should have to act fast and have to provide ease of titration of dose.it should provide rapid recovery following discontinuation early weaning from mechanical ventilation and early extubation.it has to be safe for all age groups and there should be minimal difference in age related pharmacokinetics.propofol is commonly used in ICU as a sedative agents.its advantage is rapid onset of action and rapid recovery followwing discountinuation but its has its own side effects like bradycardia,arrythmia and propofol infusion syndrome with prolonged continuous infusion.dexmedetomidine,highly selective alpha 2 agonist,has sedative and analgesic effects without causing any respiratory depression,but it may cause biphasic cardiovascular effects in dose dependant fashion.Ketamine ,NMDA receptor antagonist in the CNS,thereby inducing a state of dissociative anaesthesia and at lower dose it has analgesic and antihyperalgesic effects.it prevents respirotory efforts and airway reflexes.it has large therapeutic window but can cause tachyarrythmia and hypertension.contrary to previous literature itnhas been recently demonstraed to have favourable effects on intracranial and intraa abdominalpressures as well,it can be safely used as continuous infusion for short duration.to counteract the adverse effects and to add on the favorable effects,combination of drugs has been used nowadays,in the present literature propofol-fentanyl,midazolam-fentanyl and ketamine-propofol combination has been extensively studied.but there is paucity of studies for ketamine-dexmedetomidine combination. So the purpose of the study is to find out safety and efficacy of ketamine-dexmedetomidine in detail and to compare with ketamine-propofol combination for sedation in mechanically ventilated patients. |