| CTRI Number |
CTRI/2025/09/094392 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to find out which of combination intravenous ketamine-propofol versus ketamine -dexmedetomidine in adult patient undergoing daycare procedure is better and safe.
to see which drug combination gives better sedation, hemodynamic stabilty , less rescue bolus, and surgeon - patient satisfaction |
|
Scientific Title of Study
|
To compare efficacy of intravenous ketamine-propofol versus ketamine -dexmedetomidine in adult patient undergoing daycare procedure |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mehak |
| Designation |
post graduate resident |
| Affiliation |
Adesh institute of medical science and research |
| Address |
room no 8, adesh pg resident hostel , department of anaesthesiology and intensive care,
Adesh institute of medical science and research , Bathinda , punjab, India.
room no.8, pg resident hostel ,department of anaesthesiology and intensive care,
Adesh institute of medical science and research , Bathinda , punjab,India.
Bathinda
PUNJAB
151001
India |
| Phone |
7986851340 |
| Fax |
|
| Email |
mehak.aulakh786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Upinder kaur |
| Designation |
Professor in dept of anaesthesiology |
| Affiliation |
Adesh institute of medical science and research |
| Address |
Department of anaesthesiology and intensive care adesh institute of medical science and research
Adesh institute of medical science and research , Bathinda , punjab.
Bathinda
PUNJAB
151001
India |
| Phone |
9815033776 |
| Fax |
|
| Email |
upindermander01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mehak |
| Designation |
pg student |
| Affiliation |
Adesh institute of medical science and research |
| Address |
room no 8, adesh pg resident hostel ,
department of anaesthesiology and intensive care,
Adesh institute of medical science and research , Bathinda , punjab.
room no 8 adesh pg resident hostel ,departemnt of anaesthesiology and intensive care,
Adesh institute of medical science and research , Bathinda , punjab.
Bathinda
PUNJAB
151001
India |
| Phone |
7986851340 |
| Fax |
|
| Email |
mehak.aulakh786@gmail.com |
|
|
Source of Monetary or Material Support
|
| adesh hospital , department of anaesthesiology and intensive care,Adesh institute of medical science and research , bathinda 151001 , punjab, India. |
|
|
Primary Sponsor
|
| Name |
Mehak |
| Address |
Adesh institute of medical science and research , Bathinda , punjab. |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Mehak |
adesh hospital, Adesh institute of medical science and research |
main operating theater complex,department of anaesthsiology and intensive care, and associated venue like IVF lab, gastro endoscopy room ,bronchoscopy room, MRI. Adesh institute of medical science and research , Bathinda , punjab.
Bathinda
PUNJAB |
7986851340
mehak.aulakh786@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, Adesh University , Bathinda |
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 |
intravenous infusion of ketamine - propofol |
The study drugs will be prepared in 50-ml infusion syringes. The propofol infusion syringe contained 10 mg/ml propofol.
Ketamine infusion with concentration of 1mg/ml
Ketamine dose: 2 mL of ketamine ( 50 mg/mL)
Diluent: 48 mL of 0.9% Normal Saline (NS)
Total volume: 50 ml.
Group KP (Ketamine-Propofol) will receive an initial bolus of Propofol 1.5 mg/kg and Ketamine 1.5 mg/kg, followed by a continuous maintenance infusion of Propofol at 5 mg/kg/hr and Ketamine at 2 mg/kg/hr.
the drug will be given intravenous infusion from start of procedure till end of procedure |
| Comparator Agent |
intravenous infusion of ketamine- dexmedetomedine |
DRUG PREPARATION : The study drugs will be prepared in 50-ml infusion syringes.
Ketamine infusion with concentration of 1mg/ml
Ketamine dose: 2 mL of ketamine ( 50 mg/mL)
Diluent: 48 mL of 0.9% Normal Saline (NS)
Total volume: 50 mL
dexmedetomedine - dose 100 ug, diluent - 49ml of 0.95 normal saline , total volume = 50ml
rescue ketamine dose concentration 10mg/ml.
Group KD (Ketamine-Dexmedetomidine) will receive an initial bolus of Dexmedetomidine 1 µg/kg Over 10 minutes and Ketamine 2 mg/kg, followed by a maintenance infusion of Dexmedetomidine at 1 µg/kg/hr and Ketamine at 1.5 mg/kg/hr.
the drug will be given intravenous infusion from strat of infusion till end of infusion.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical status I or II
Scheduled for elective daycare procedure
willing and able to provide written consent
BMI between 18.5 to 29.9
Procedure duration less than 60 minutes |
|
| ExclusionCriteria |
| Details |
1)known allergy to any of study drug
2)history of cardiovascular, hepatic, renal or psychiatric disorder
3)pregnancy or lactation
4)chronic use of sedative or opioids |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To compare the demand of rescue anaesthetic during procedure.
2)2) To compare time require to achieve adequate and effective sedation for procedure ( Ramsay sedation score 5 ) between the study groups.
|
Time from start of infusion to achieve RSS 5
( ramsay sedation score )
from start of infusion , patient movement will be noted. if any movement is seen , that time will be documented. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
) To compare the time to eye opening after cessation of infusion of study drugs between study groups.
2) To compare the recovery time between the two study groups
3)To compare the incidence of respiratory & airway-related complications between the two study groups
4) To assess & compare surgeon & patient satisfaction across both groups by using 3 point scale .
|
time from stop of infusion till recovery.
hemodynamice parameters will be notes at base line,
3 minutes
6 minutes
9 minutes
12 minutes
15 minutes
20 minutes
25 minutes
30 minutes
40 minutes
50 minutes
60 minutes |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/10/2025 |
| 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="6"
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
|
This study aims to contribute to existing literature by comparing the efficacy of intravenous ketamine- propofol versus ketamine dexmedetomedine in adult patient undergoing daycare procedure .the main focus is to evaluate the need of rescue bolus required after infusion , time taken to achive adeqaute sedation and effective sedation . through this research , we strive to provide valuable insights aimed at safer and more efficacious choice for procedural sedation in short surgical procedure. |