| CTRI Number |
CTRI/2024/09/073527 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prevalence of delirium in the elderly patients undergoing surgery |
|
Scientific Title of Study
|
Evaluation Of Prevalence Of Post-operative Delirium Among Elderly Patients Undergoing Elective 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 |
Parvathy S |
| Designation |
Postgraduate Resident |
| Affiliation |
Amrita Institute Of Medical Sciences,Kochi |
| Address |
Department of Anaesthesiology
Amrita Institute of Medical Sciences,
Ponekkara P.O
Kochi, Ernakulam
Ernakulam
KERALA
682041
India |
| Phone |
7012212795 |
| Fax |
|
| Email |
parvathy007suresh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyam Sundar P |
| Designation |
Additional Professor |
| Affiliation |
Amrita Institute Of Medical Sciences,Kochi |
| Address |
Department of Anaesthesiology AIMS,Ponekkara P.O ,Kochi, Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9895093011 |
| Fax |
|
| Email |
shyamsundarp@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyam Sundar P |
| Designation |
Additional Professor |
| Affiliation |
Amrita Institute Of Medical Sciences,Kochi |
| Address |
Department of Anaesthesiology AIMS,Ponekkara P.O ,Kochi, Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9895093011 |
| Fax |
|
| Email |
shyamsundarp@aims.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Amrita Institute Of Medical Sciences,Kochi , Kerala, India , Pin code : 682041 |
|
|
Primary Sponsor
|
| Name |
Parvathy S |
| Address |
Amrita Institute of Medical Sciences, Kochi, Kerala, India, Pin code-682041 |
| 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 Shyam Sundar P |
Amrita Institute Of Medical Sciences,Kochi |
Department of Anaesthesiology, Ponekkara P.O, Kochi , Kerala, India
Pin code- 682041
Ernakulam
KERALA |
9895093011
shyamsundarp@aims.amrita.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Of Amrita School Of Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Elderly patients more than 60 years of age who are undergoing elective surgery during the study period in our institute |
|
| ExclusionCriteria |
| Details |
1-patients who are unconscious post operatively (Delirium screening cannot be done in such patients)
2-Patients with pre-existing psychiatric problems
3-Patients who are ventilated post operatively and are receiving sedatives |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative delirium |
Within 24 hours of post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the association between Peri operative factors (Age,ASA status, Baseline Hemoglobin level, Type of Anaesthesia,Duration of surgery, Post operative pain) and post-operative delirium in the elderly patient undergoing elective surgery |
Within 24 hours of post operative period |
|
|
Target Sample Size
|
Total Sample Size="1008"
Sample Size from India="1008"
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)
|
16/09/2024 |
| 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="0"
Months="4"
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
|
It is a prospective observational study to be conducted in elderly patients ,more than 60 years of age, undergoing elective surgery during the study period in our institute. Patients will be screened for delirium in the post-operative period (within 24 hours). Peri-operative factors such as Age, ASA status, Baseline haemoglobin level, Type of anaesthesia, Duration of surgery, Post-operative pain shall be noted and analysed in the study ( association between perioperative factors and post operative delirium) |