| CTRI Number |
CTRI/2020/06/026136 [Registered on: 25/06/2020] Trial Registered Prospectively |
| Last Modified On: |
24/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Post-operative cognitive dysfunction |
|
Scientific Title of Study
|
Post-operative cognitive dysfunction in elderly patients undergoing elective orthopaedic lower limb surgeries under central neuraxial anaesthesia |
| Trial Acronym |
POCD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sundeep Goud E |
| Designation |
Junior Resident |
| Affiliation |
VIMS, Bellary |
| Address |
Department of Anaesthesiology, Vijayanagar institute of Medical Sciences, Cantonment, Ballari.
Department of Anaesthesiology, Vijayanagar institute of Medical Sciences, Cantonment, Ballari.
Bellary
KARNATAKA
583101
India |
| Phone |
09663810059 |
| Fax |
|
| Email |
sundeepgoude@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devanand B |
| Designation |
Professor and HOD |
| Affiliation |
VIMS, BELLARY. |
| Address |
Department of Anaesthesiology, Vijayanagar institute of Medical Sciences, Cantonment, Ballari.
Department of Anaesthesiology, Vijayanagar institute of Medical Sciences, Cantonment, Ballari.
Bellary
KARNATAKA
583104
India |
| Phone |
|
| Fax |
|
| Email |
Dr.devanand.b@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sundeep Goud E |
| Designation |
Junior Resident |
| Affiliation |
VIMS, BELLARY. |
| Address |
Department of Anaesthesiology, Vijayanagar institute of Medical Sciences, Cantonment, Ballari.
Department of Anaesthesiology, Vijayanagar institute of Medical Sciences, Cantonment, Ballari.
Bellary
KARNATAKA
583101
India |
| Phone |
09663810059 |
| Fax |
|
| Email |
sundeepgoude@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vijayanagar institute of medical sciences , Ballari , |
|
|
Primary Sponsor
|
| Name |
Vijayanagar institute of Medical Sciences |
| Address |
Cantonment, Ballari. 583104 |
| 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 |
| Sundeep Goud E |
VIMS , BELLARY |
Department of Anaesthesiology, Major Ot complex, Cantonment, Bellary
Bellary
KARNATAKA |
09663810059
sundeepgoude@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vims institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F068||Other specified mental disorders due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I-III |
|
| ExclusionCriteria |
| Details |
Refusal by patients for the procedure
Patients with pre existing cognitive dysfunction
Patients who presented with MMSE less than 23
Pre existing cardiac disease, neurological condition, severe respiratory disease etc
Coagulopathy
Allergy to drugs used |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the incidence of changes of cognitive functions of elderly patients before and after elective Orthopaedic lower limb surgery before and after central neraxial blockade |
To study the incidence of changes of cognitive functions of elderly patients before and after elective Orthopaedic lower limb surgery before and after central neraxial blockade |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find correlation with regard to age, sex, time duration, drugs etc |
1 year |
|
|
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)
|
29/06/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will help us in finding cognitive dysfunction in elderly patients so that we improve the patient betterment postoperatively |