| CTRI Number |
CTRI/2025/07/091419 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect and haemodynamic stability associated with two intravenous drug combination -Ketamine and Dexmedetomidine with Propofol for total intravenous anaesthesia. |
|
Scientific Title of Study
|
A cross-sectional study on comparing the effects of two techniques, Propofol Ketamine and Dexmedetomidine ketamine, in Total Intravenous Anaesthesia (TIVA) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Emmima Praisy |
| Designation |
BSc -AHS- intern student |
| Affiliation |
Sree Balaji Medical College and Hospital |
| Address |
Students- Intern room 3rd Floor Sree Balaji Medical College hospital complex CLC works road Chrompet Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
7397105293 |
| Fax |
|
| Email |
praicy7112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kala Balasubramanian |
| Designation |
Professor of Anesthesiology |
| Affiliation |
BIHER university |
| Address |
Department of Anesthesiology, Room No. 2, OBG OT complex, First Floor, Sree Balaji Medical College Hospital, Chrompet, Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9444680908 |
| Fax |
|
| Email |
kalamhn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Kala Balasubramanian |
| Designation |
Professor of Anesthesiology |
| Affiliation |
Sree Balaji Medical College and Hospital |
| Address |
Department of Anesthesiology, Room No. 2, OBG OT complex, First Floor, Sree Balaji Medical College Hospital, Chrompet, Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9444680908 |
| Fax |
|
| Email |
kalamhn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Balaji Medical College and Hospital, No. 7, C.L.C. Works Road, Chrompet, Chennai, Tamil Nadu 600044. India |
|
|
Primary Sponsor
|
| Name |
Sree Balaji Medical College and Hospitals |
| Address |
Department of Anaesthesia, No. 7 CLC Works Road, Chrompet, Chennai, Tamil Nadu, India. 600044 |
| Type of Sponsor |
Private 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 |
| Prof Dr Kala Balasubramanian |
Sree Balaji Medical college hospital |
Department of Anesthesia, First floor-OBG OT complex, No 7 CLC works road Chrompet Chennai, Tamil Nadu, India 600044
Chennai
TAMIL NADU |
9444680908
kalamhn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SCHOOL OF ALLIED HEALTH SCIENCES SREE BALAJI MEDICAL COLLEGE & HOSPITAL Bharath Institute of Higher Education and Research The Institutional Review Board |
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 |
Group DK (Dexmedetomidine and Ketamine for TIVA |
Group DK will receive a bolus dose of Inj. Dexmedetomidine 1micgmper kg BW and Inj.Ketamine 1mgper kg BW slow IV followed by Inj.Dexmedetomidine 1 mcg/kg/hour and Inj.Ketamine 1mg/kg/hour slow IV infusion. |
| Intervention |
Group PK (Propofol and Ketamine for TIVA |
Group PK will receive a bolus dose of Inj. Propofol 2mg/kgBW and Inj.Ketamine 1mg per kgBW slow IV followed by Inj.Propofol 1mg/kg/hour and Inj.Ketamine 1mg/kg/hour slow IV infusion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Short duration surgical procedures that can be done under Total intravenous anaesthesia
2. Patients who are under ASA-Grade I and II without any Comorbid diseases in the age group between 20-50 years.
3. Patients who are willing to participate in this study |
|
| ExclusionCriteria |
| Details |
Pediatric and Geriatric age group patients
Patients who gave a history of being allergic to this group of drugs
Major surgical procedures that require complex anaesthetic or interventional techniques
Refusal to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the quality of surgical anaesthesia induced by the combination of study drugs and the haemodynamic stability |
1. Pre-operative baseline vital parameters
Intraoperative vital parameters and duration of anaesthesia 0.5.10,15,30,45,60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post-operative recovery score & post-operative duration of analgesia, & time for rescue analgesia |
By using Ramsey sedation scoring & VAS scoring postoperatively at 0,15,30,45 minutes, & hourly till 6hours or the time for rescue analgesia -whichever is earlier |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Adults of age group between 20 to 50 years of both genders posted for elective surgeries of short procedure and short duration will be selected based on the inclusion criteria. they will be randomly divided into Group PK and Group DK will receive either propofol and ketamine or dexmedetomidine and ketamine. The duration of surgery total dose of drug requirement hemodynamic stability post operative recovery post operative pain relief wil be assess between the two groups wnd will be analysed for final interpretation |