| CTRI Number |
CTRI/2025/08/093662 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Diagnostic
Preventive
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing how well Dexmedetomidine works when given through the bloodstream versus near the nerves , along with regional anaesthesia , to help protect brain function after surgery in older patients undergoing orthopedic operations. |
|
Scientific Title of Study
|
Efficacy of Dexmedetomidine intravenously versus perineurally as an adjunct to regional anaesthesia on
post-operative cognitive dysfunction in elderly patients posted for orthopaedic surgery -A randomised controlled 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 Pragya Darshika |
| Designation |
Post Graduate Resident , Department of Anaesthesiology |
| Affiliation |
Kalinga Institute of Medical Sciences , Bhubaneswar |
| Address |
Kalinga Institute of Medical Sciences , Bhubaneswar
Department of Anaesthesiology, Kalinga Institute of Medical Sciences , Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
8789891838 |
| Fax |
|
| Email |
pragyadarshika478@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrita Panda |
| Designation |
Professor and Head of the Department , Department of Anaesthesiology |
| Affiliation |
Kalinga Institute of Medical Sciences , Bhubaneswar |
| Address |
Kalinga Institute of Medical Sciences , Bhubaneswar
Professor and Head of the Department , Department of Anaesthesiology, Kalinga Institute of Medical Sciences , Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9439862335 |
| Fax |
|
| Email |
amrita.panda@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Panda |
| Designation |
Professor and Head of the Department , Department of Anaesthesiology |
| Affiliation |
Kalinga Institute of Medical Sciences , Bhubaneswar |
| Address |
Kalinga Institute of Medical Sciences , Bhubaneswar
Professor and Head of the Department , Department of Anaesthesiology, Kalinga Institute of Medical Sciences , Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9439862335 |
| Fax |
|
| Email |
amrita.panda@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Sciences, Bhubaneswar, Orissa , Khordha , 751024 |
|
|
Primary Sponsor
|
| Name |
Kalinga Institute of Medical Sciences, Bhubaneswar |
| Address |
Kushabhadra Campus 5, KIIT Road , Bhubaneswar , Odisha-751024 |
| 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 |
| Dr Pragya Darshika |
Kalinga Institute of Medical Sciences |
Kalinga Institute of Medical Sciences, Kushabhadra
Campus 5, KIIT Road,
Bhubaneswar
Khordha
ORISSA |
08789891838
pragyadarshika478@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kalinga Institute of Medical Sciences ( KIMS), KIIT Deemed to be University, Bhubaneswar 751024 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S798||Other specified injuries of hip and thigh, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Dexmedetomidine |
This group is given Subarachnoid Block and Dexmedetomidine infusion of 0.5 mcg/kg/hr is started just prior to incision and is stopped 15 minutes just prior to closure. |
| Comparator Agent |
Perineural Dexmedetomidine |
This group is given USG guided Pericapsular Nerve Group Block with 15 ml of 0.20% Ropivacaine and 0.5 mcg/kg Dexmedetomidine in pre-operative room under all appropriate available aseptic conditions followed by routine Subarachnoid Block . |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
98.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled for elective proximal femur nailing.
2. American Society of Anaesthesiologist (ASA) physical status I-III .
3. Patients aged 50 years and older (defined as ‘elderly’ as per WHO )
|
|
| ExclusionCriteria |
| Details |
1. Patients with haemodynamic instability
2. Known history of psychiatric illness , previous history of dementia , delirium, head injury
3. History of allergy to anaesthetic drugs
4. Contraindications to regional anaesthesia
5. Failed Central Neuraxial Block
6. Patients with communication or hearing or speech impairment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence of post-operative cognitive dysfunction using Montreal Cognitive Assessment (MoCA) Score in both the groups |
at 72 hours after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of postoperative cognitive dysfunction using MoCA score
|
24hours pre-operatively followed by 72hours post-operatively |
| Time taken to first ambulation is assessed. |
0 hours post-operatively |
| To evaluate correlation of C-reactive protein levels with incidence of post-operative cognitive dysfunction in both the groups . |
pre-operatively followed by post-operatively at 72 hours |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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)
|
09/09/2025 |
| 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 Applicable |
| 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
|
The study is designed to compare the effect of Dexmedetomidine intravenously versus perineurally as an adjunct to regional anaesthesia on post-operative cognitive dysfunction in elderly patients posted for orthopaedic surgery.
The primary goal of the research is to compare the incidence of post-operative cognitive dysfunction in both the study groups using MoCA score at 72 hours post -operatively.
By comparing the effect of Dexmedetomidine intravenously versus perineurally as an adjunct to regional anaesthesia on post-operative cognitive dysfunction (POCD) in elderly patients posted for orthopaedic surgery , the intervention which decreases the incidence of POCD in elderly population posted for orthopaedic surgery could be determined which will help in it’s management in a timely manner, thus preventing permanent cognitive decline in some patients , better functional recovery, decreased hospitalization stay and overall decreased mortality rate. |