| CTRI Number |
CTRI/2026/01/102255 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
comparative study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of sedative effects of 2 drugs(dexmedetomidine and remifentanyl)in patients posted for heart valve replacement procedure done by cardiologists |
|
Scientific Title of Study
|
Comparison of continuous infusion of dexmedetomidine vs remifentanyl for conscious sedation in patients undergoing transcatheter aortic valve replacement -a single blinded randomized control trial |
| 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 Christy Pius Kaliyadan |
| Designation |
DrNB resident |
| Affiliation |
Medanta the medicity |
| Address |
1233,Islampur colony
Behind Medanta the medicity
sector 38
Gurgaon,Haryana
Gurgaon
HARYANA
122001
India |
| Phone |
9539747439 |
| Fax |
|
| Email |
christy.pious725@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yatin Mehta |
| Designation |
Chairman,department of anaesthesia and critical care |
| Affiliation |
Medanta the medicity |
| Address |
1st floor,Department of cardiac anaesthesia
Medanta the medicity
sector 38
Gurgaon,Haryana
HARYANA
122001
India |
| Phone |
9539747439 |
| Fax |
|
| Email |
Yatin.mehta@medanta.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Christy Pius Kaliyadan |
| Designation |
DrNB resident |
| Affiliation |
Medanta the medicity |
| Address |
1233,Islampur colony
Behind Medanta the medicity
sector 38
Gurgaon,Haryana
HARYANA
122001
India |
| Phone |
9539747439 |
| Fax |
|
| Email |
christy.pious725@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medanta the medicity
Sector 38
Gurgaon
Haryana,122001 |
|
|
Primary Sponsor
|
| Name |
Medanta the medicity |
| Address |
Medanta the medicity
CH Bhaktawar Singh road
sector 38,Gurgaon,Haryana,122001
Gurgaon,Haryana |
| 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 Christy pius kaliyadan |
Medanta the medicity |
Medanta the medicity
CH Bhaktawar Singh road
sector 38,Gurgaon,Haryana,122001
Gurgaon
Haryana
Gurgaon
HARYANA |
9539747439
christy.pious725@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I350||Nonrheumatic aortic (valve) stenosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
patients more than 60 years with severe aortic stenosis with symptoms such as chest pain,palpitation and with preserved systolic funtion |
|
| ExclusionCriteria |
| Details |
recent MI or stroke within last 6 months,CAD,patients not giving consent,EF less than 60 percent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| sedative effects (Ramsay Sedation Score)and hemodynamic parameters of both sedative effects and hemodynamic parameters of both remifentanyl and dexmedetomidine remifentanyl and dexmedetomidine |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| postoperative delirium,postoperative nausea and vomiting,length of ICU and hospital stay,adverse events,conversion to GA |
1 year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
07/02/2026 |
| 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
|
patients will be grouped into two groups.Group D will receive dexmeditomidine and group R will receive remifentanyl and comparison of sedative effects of both these drugs on sedation will be done in patients undergoing transcatheter aortic valve replacement.Other parameters like ABG and hemodynamics will be recorded.postoperative delirium,length of ICU stay,postoperative nausea and vomiting,patient and cardiologist satisfaction and BIS values will also be recorded.And we expect remifentanyl to a a better hemodynamic and sedative effects than dexmedetomidine with lesser or no adverse events. |