| CTRI Number |
CTRI/2025/09/094238 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
How preoperative frailty and muscle weakness affect memory and thinking after surgery in older patients |
|
Scientific Title of Study
|
Preoperative frailty index and sarcopenia as predictors of postoperative cognitive dysfunction in elderly patients undergoing orthopedic surgery under spinal anaesthesia a prospective observational study. |
| 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 Divya S |
| Designation |
First Year Postgraduate |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Main OT complex
Room no.1,13-A,Pondy-Villupuram Main Road, Sri Venkateshwaraa Medical College Hospital and Research Centre, Ariyur, Puducherry.
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9384942236 |
| Fax |
|
| Email |
email2divya97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnaprabu R |
| Designation |
Professor and HOD |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Main OT complex,
Room no.1, 13-A,Pondy-Villupuram Main Road, Sri Venkateshwaraa Medical College Hospital and Research Centre, Ariyur, Puducherry.
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9943770977 |
| Fax |
|
| Email |
drkrishnaprabu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishnaprabu R |
| Designation |
Professor and HOD |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Main OT complex,
Room no.1, 13-A,Pondy-Villupuram Main Road, Sri Venkateshwaraa Medical College Hospital and Research Centre, Ariyur, Puducherry.
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9943770977 |
| Fax |
|
| Email |
drkrishnaprabu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa Medical College Hospital and Research Centre
Department of Anaesthesiology, Main OT complex,Room no.1,
13-A,Pondy-Villupuram Main Road, Sri Venkateshwaraa Medical College Hospital and Research Centre, Ariyur, Puducherry.
Pondicherry
PONDICHERRY
605102 |
|
|
Primary Sponsor
|
| Name |
Dr Divya S |
| Address |
Sri Venkateshwaraa Medical College Hospital and Research Centre,
13-A,Pondy-Villupuram Main Road, Ariyur, Puducherry, India.
605102. |
| 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 |
| Dr Divya S |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
Department of Anaesthesiology, Main OT complex
Room no.1,13-A,Pondy-Villupuram Main Road, Sri Venkateshwaraa Medical College Hospital and Research Centre, Ariyur, Puducherry.
Pondicherry
PONDICHERRY |
9384942236
email2divya97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F05||Delirium due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Scheduled to undergo elective orthopaedic surgery under spinal anaesthesia.
2.Age 65 years and above
3.Belonging to American society of Anesthesiologists (ASA) class I, II, III
4.Able to provide informed consent
5.Had a baseline Addenbrooke’s Cognitive Examination-III (ACE-III) score of more than 88
|
|
| ExclusionCriteria |
| Details |
1.Use of sedatives or conversion to general anaesthesia
2.Active alcohol abuse or chronic opioid/substance abuse
3.Pre-existing diagnosis of moderate to severe dementia or other major neurocognitive disorders.
4.History of psychiatric illness that may affect cognitive assessment (e.g., schizophrenia, major depression with psychosis).
5.Patients with neuromuscular disorders affecting hand grip strength (e.g., Parkinson’s disease, stroke with motor deficits).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between preoperative frailty measured by 5-factor Modified Frailty Index 5mFI and postoperative cognitive dysfunction. |
Association between preoperative frailty measured by 5-factor Modified Frailty Index 5mFI and postoperative cognitive dysfunction measured by ACE III preoperative baseline and 24 hours and 72 hours after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between sarcopenia assessed by hand grip strength & post operative cognitive dysfunction. |
Association between sarcopenia assessed by hand digital dynamometer & postoperative cognitive dysfunction measured by ACE III preoperative baseline & 24 hours & 72 hours after surgery. |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
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)
|
15/09/2025 |
| 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 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 prospective observational study evaluates whether preoperative frailty 5mFI and sarcopenia hand grip strength predict postoperative cognitive dysfunction POCD in elderly patients undergoing orthopaedic surgery under spinal anaesthesia. Cognitive function will be assessed using Addenbrooke’s Cognitive Examination III ACE III preoperatively and at 24 & 72 hours postoperatively. The study aims to identify high-risk patients early, enabling targeted perioperative care and improved outcomes. |