| CTRI Number |
CTRI/2026/02/104926 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to assess whether frailty increases the risk of confusion (delirium) after hip surgery in patients aged 60 years and above |
|
Scientific Title of Study
|
Impact of frailty on postoperative delirium in patients above 60 years undergoing elective hip surgeries 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 Ashwini S |
| Designation |
Associate Professor |
| Affiliation |
Shivmogga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Shivamogga Institute of Medical Sciences, Shimoga, Karnataka, 577201
Department of Anaesthesiology
Shivamogga Institute of Medical Sciences, Shimoga, Karnataka, 577201
Shimoga
KARNATAKA
577201
India |
| Phone |
9980812398 |
| Fax |
|
| Email |
ashwini.satrasala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini S |
| Designation |
Associate Professor |
| Affiliation |
Shivamogga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Shivamogga Institute of Medical Sciences, Shimoga, Karnataka, 577201
Department of Anaesthesiology
Shivamogga Institute of Medical Sciences, Shimoga, Karnataka, 577201
Shimoga
KARNATAKA
577201
India |
| Phone |
9980812398 |
| Fax |
|
| Email |
ashwini.satrasala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini S |
| Designation |
Associate Professor |
| Affiliation |
Shivamogga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Shivamogga Institute of Medical Sciences, Shimoga, Karnataka, 577201
Department of Anaesthesiology
Shivamogga Institute of Medical Sciences, Shimoga, Karnataka, 577201
Shimoga
KARNATAKA
577201
India |
| Phone |
9980812398 |
| Fax |
|
| Email |
ashwini.satrasala@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shivamogga Institute of Medical Sciences |
| Address |
Shivamogga Institute of Medical Sciences, Sagar Road, Mission Compound, Shivamogga, Karnataka, 577201 |
| Type of Sponsor |
Government 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 Ashwini S |
Shivamogga Institute of Medical Sciences |
Department of Anaesthesiology, Major OT Complex, 3rd Floor, Mcgann Teaching District Hospital, Shivamogga Institute of Medical Sciences, Sagar Road, Mission Compound, Shivamogga, Karnataka 577201
Shimoga
KARNATAKA |
9980812398
ashwini.satrasala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) SIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
patient beloning to american society of anaesthesiologist physical status one to three
patients undergoing elective hip surgery
patients who are willing to give informed consent for the study |
|
| ExclusionCriteria |
| Details |
Preexisting diadnosed dementia or psychiatric illness
patients on medication for psychiatric illness
patients on mechanical ventilation perioperatively
patients inability to cooperate in assessments like those with sensory impairment visually challenged hearing impairment amd mute patients
patients with preexisting alcohol withdrawal syndrome |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the association between frailty and the development of postoprative delirium in patients aged more than 60 years undergoing elective hip surgeries |
day 1
day 2
day 3
day 4
day 5
after surgery
each day post oprative delirium present or absent to be noted using 3 d cam and 4 assessment tests for delirium amd cognitive impairment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate the incidence of post operative delirium in study population
To determine the prevalence of frailty based on modified frailty index 11 point criteria in patients undergoing elective hip surgeris |
day 1
day 2
day 3
day 4
day 5
after surgery
each day post oprative delirium present or absent to be noted using 3 d cam and 4 assessment tests for delirium amd cognitive impairment |
|
|
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)
|
05/04/2026 |
| 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="2"
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
|
To evaluate the association between frailty and the development of post operative delirium in patients aged more than 60 years undergoing elective hip surgeries based o 3d cam and 4 assessment test for delirium and cognitive dysfunction. To estimate the incidence of post operative delirium in study population To determine the prevalence of frailty based on modified frailty index 11 point criteria in patients undergoing elective hip surgeries |