| CTRI Number |
CTRI/2025/07/091487 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Using a Simple Memory Test to Predict Confusion After Hip Surgery in Older Adults
|
|
Scientific Title of Study
|
A study on the use of Mini-Cog Test to predict Postoperative Delirium in
patients with Hip Fractures undergoing Surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahesh K M |
| Designation |
Post Graduate |
| Affiliation |
ESIC Medical College and Hospital,K.K.Nagar,Chennai-600078. |
| Address |
NO 1/83,Palla Street,Agraharam, Korattur,Chennai-600076.
ESIC Medical College and Hospital,K.K.Nagar,Chennai-600078.
Chennai
TAMIL NADU
600076
India |
| Phone |
9345012218 |
| Fax |
|
| Email |
marsh.meclaren@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nataraj M S |
| Designation |
Head of the Department |
| Affiliation |
ESIC Medical College and Hospital,K.K.Nagar,Chennai-600078. |
| Address |
ESIC Medical College and Hospital,K.K.Nagar,Chennai-600078.
Chennai
TAMIL NADU
600078
India |
| Phone |
9886571461 |
| Fax |
|
| Email |
natarajms23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahesh K M |
| Designation |
Post Graduate |
| Affiliation |
ESIC Medical College and Hospital,K.K.Nagar,Chennai-600078. |
| Address |
No-1/83,Palla Street, Agraharam,Korattur,Chennai-600076.
ESIC Medical College and Hospital,K.K.Nagar,Chennai-600078.
Chennai
TAMIL NADU
600076
India |
| Phone |
9345012218 |
| Fax |
|
| Email |
marsh.meclaren@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital,K.K.Nagar,Chennai-600078. |
|
|
Primary Sponsor
|
| Name |
ESIC Medical College and Hospital |
| Address |
K.K.Nagar,Chennai-600078. |
| 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 Mahesh K M |
ESIC Medical College and Hospital |
Department of Anaesthesiology,K.K.Nagar,Chennai-600078.
Chennai
TAMIL NADU |
09345012218
marsh.meclaren@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ESIC Medical College and Hospital |
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 |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
89.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing the study with written consent given who are 65-89 years of age under ASA I and II.
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal for the study
2.Patients who are not cooperative for the assessment
3.Patient with Hearing or Visual Impairment
4.Patients with Pre existing neurological disorders
5.Patients undergoing surgery under general anaesthesia
6.ASA physical status of III and above |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess whether positive preoperative cognitive impairment screening by Mini-Cog is
associated with the occurrence of postoperative delirium in elderly patients undergoing hip
surgery. |
24 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To implement the Mini-cog test as a routine cognitive screening tool in elderly patients
undergoing hip surgery. |
24 Hours |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
15/08/2025 |
| 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="10"
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
|
A Prospective Observational Cohort Study which includes patients undergoing Hip Surgeries. The procedure will be explained to the patient and the informed consent will be obtained. Baseline demographic and clinical information—such as age, sex, medical comorbidities, current medications, and type of surgery—is recorded. The Mini-Cog test is administered preoperatively, ideally within the first 24 hours of hospital admission and before any premedication or sedation that might interfere with cognitive testing. It consists of two components: a three-word recall and a clock-drawing task. To begin the test, the patient is told three unrelated words (e.g., “apple,” “watch,” “table”) and asked to repeat them to ensure they have heard and understood. Next, the patient is instructed to draw a clock: they are asked to draw a circle, place the numbers to make it look like a clock, and then set the hands to a specific time (e.g., “10 past 11”). After completing the clock, the patient is asked to recall the three words given earlier. Scoring is done out of five: one point for each word correctly recalled (up to three points) and two points for a correctly drawn and properly set clock. A total score of 0–2 suggests possible cognitive impairment, while a score of 3–5 is considered normal. This score is recorded immediately. Patients are then assessed postoperatively after a period of 24 hours. Postoperatively, patients will be assessed after a period of 24 hours using the Confusion Assessment Method (CAM). Delirium was diagnosed based on: 1. Acute onset and fluctuating course 2. Inattention 3. Disorganized thinking 4. Altered level of consciousness Delirium was diagnosed if criteria 1 and 2, plus either 3 or 4, were present. |