| CTRI Number |
CTRI/2026/01/101353 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Post-Surgery Memory and Cognitive Changes in Elderly Patients Undergoing Urogynaecological Surgery |
|
Scientific Title of Study
|
Study of Postoperative Cognitive Dysfunction in Elderly Patients undergoing Urogynaecological Surgeries under General 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 |
Vinootha Vinay Nyamati |
| Designation |
Dr |
| Affiliation |
JSS Medical College and Hospital, Mysuru |
| Address |
JSS Medical College and Hospital
Department of Anaesthesia
Mahatma Gandhi Road, Fort Mohalla
Mysore, Karnataka 570004
Department of Anaesthesia
Mahatma Gandhi Road, Fort Mohalla
Mysore, Karnataka 570004
Mysore
KARNATAKA
570004
India |
| Phone |
08355825384 |
| Fax |
|
| Email |
vinuthanyamati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Srinivas H T |
| Designation |
Prof |
| Affiliation |
JSS Medical College and Hospital Mysuru |
| Address |
JSS Medical College
Department of Anaesthesia
Mahatma Gandhi Road, Fort Mohalla
Mysore
Department of Anaesthesia
Mahatma Gandhi Road, Fort Mohalla
Mysore, Karnataka 570004
Mysore
KARNATAKA
570004
India |
| Phone |
9986079823 |
| Fax |
|
| Email |
drsrinivashtjss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Srinivas H T |
| Designation |
Prof Dr |
| Affiliation |
JSS Medical College and Hospital Mysuru |
| Address |
JSS Medical College
Department of Anaesthesia
Mahatma Gandhi Road, Fort Mohalla
Mysore
Department of Anaesthesia
Mahatma Gandhi Road, Fort Mohalla
Mysore, Karnataka 570004
Mysore
KARNATAKA
570004
India |
| Phone |
9986079823 |
| Fax |
|
| Email |
drsrinivashtjss@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Medical College and Hospital
Mahatma Gandhi Road, Fort Mohalla
Mysuru, Karnataka 570004
India |
|
|
Primary Sponsor
|
| Name |
DR VINOOTHA VINAY NYAMATI |
| Address |
JSS Medical College and Hospital
Mahatma Gandhi Road (M. G. Road), Fort Mohalla,
Mysuru |
| 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 |
| Vinootha Vinay Nyamati |
JSS Medical College and Hospital |
Department of Anaesthesia
Mahatma Gandhi Road, Fort Mohalla
Mysore, Karnataka 570004
India
Mysore
KARNATAKA |
08355825384
vinuthanyamati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, (2) ICD-10 Condition: N950||Postmenopausal bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Elderly population on ASA grade I, II and III aged more than 60 years scheduled for general surgeries under GA
2. Patients with normal cognitive function according to MoCA score of 24 to 30
3. Kannada, Hindi or English as their native language and should be able to verbally communicate and give consent in writing
|
|
| ExclusionCriteria |
| Details |
1. Unwillingness of patients to give consent
2. Patients with prior cognitive disorder or delirium assessed by Confusion Assessment Method (CAM)
3. Patients who are on psychiatric medications
4. Patients with any neurological diseases (Eg Stroke, Parkinson’s Disease) included in the International Statistical Classification of diseases and related health problems (ICD 10)
5. Any past history of alcohol or drug abuse
6. Patients with any acid base disorders or electrolyte disturbances.
7. Surgeries in which the mode of anesthesia was changed due to any reason
8. Patients who are unable to perform the MoCA questionnaire due to impaired vision or auditory functions.
9. Patients with literacy of less than 10th Standard.
10. Surgeries lasting for longer than 4 hours
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To look for cognitive function using MoCA test |
Postoperative Day 1, 2 and 90 days post-surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the prevalence of Postoperative Cognitive Dysfunction (POCD) in elderly patients. |
Postoperative Day 1, 2 and 90 days post-surgery |
| To find out the recovery time from POCD among elderly patients |
Postoperative Day 1, 2 and 90 days post-surgery |
| To establish the efficacy of Montreal Cognitive Assessment (MoCA) in determining the occurrence of POCD in elderly patients |
Postoperative Day 1, 2 and 90 days post-surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/01/2026 |
| 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 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
|
This study is a Prospective Observational study, done to study the post operative cognitive functions of elderly patients undergoing Urogynaecological surgery after exposing them to General Anaesthesia in total number of 60 patients including men and women above the age of 60 years. Patients will be admitted at least 1-2 days prior to surgery. Pre- operative assessment will be done on patients using the Montreal Cognitive Assessment (MoCA) and then Postoperative cognitive status is also examined either in person or by telephone using MoCA on Day 1, 2 and 90.
|