| CTRI Number |
CTRI/2023/11/059933 [Registered on: 17/11/2023] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The role disease condition such as obesity, diabetes and high blood pressure called as “metabolic syndrome†in leading to a confused state or intellectual impairment or disability after elderly patients after surgery.
|
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Scientific Title of Study
|
Role of Metabolic Syndromes (MetS) in the Incidence of Post-Operative Delirium and Cognitive Dysfunction in Elderly Patients Undergoing Major Surgery 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 |
Dr Puneet Khanna |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Delhi |
| Address |
5th Floor Teaching block
Department of Anaesthesia Pain Medicine and Critical Care
AIIMS Delhi
South
DELHI
110029
India |
| Phone |
9873106526 |
| Fax |
|
| Email |
k.punit@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Choro Athiphro Kayina |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Delhi |
| Address |
5th Floor Teaching block
Department of Anaesthesia Pain Medicine and Critical Care
AIIMS Delhi
South
DELHI
110029
India |
| Phone |
9654116228 |
| Fax |
|
| Email |
kayinaathiphro@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Choro Athiphro Kayina |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Delhi |
| Address |
5th Floor Teaching block
Department of Anaesthesia Pain Medicine and Critical Care
AIIMS Delhi
South
DELHI
110029
India |
| Phone |
9654116228 |
| Fax |
|
| Email |
kayinaathiphro@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Puneet Khanna |
| Address |
5th Floor Teaching block
Department of Anaesthesia Pain Medicine and Critical Care AIIMS Delhi
AIIMS Delhi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Choro Athiphro Kayina |
All India Institute of Medical Science Delhi |
5th Floor Teaching block
Department of Anaesthesia Pain Medicine and Critical Care
AIIMS Delhi
South
DELHI |
9654116228
kayinaathiphro@gmail.com |
| Dr Puneet Khanna |
All India Institute of Medical Sciences Delhi |
5th floor Teaching Block Department of Anaesthesia Pain Medicine and Critical Care AIIMS New Delhi
South
DELHI |
9873106516
k.punit@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 60years undergoing surgery under general anaesthesia belonging to American society of Anaesthesiologist physical status I or II |
|
| ExclusionCriteria |
| Details |
1. Patients with a history suggestive of psychiatric disease like schizophrenia, dementia, and anxiety or other neurological disorder affecting cognition, mental dysfunction.
2. History of cerebral surgeries, stroke.
3. Prescription of central nervous system–active medication (e.g. antidepressants,
antipsychotics, sedatives)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the association of metabolic syndrome in the incidence of Post- operative delirium and cognitive dysfunction in elderly population undergoing major surgery under general anaesthesia. |
Post operative delirium at 24 hours and 72 hours after surgery
Post operative Cognitive Dysfunction at 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the incidence of POD and POCD at pre and post operatively through neurocognitive scale.
2. Study the risk of Postoperative Delirium and Postoperative Cognitive Dysfunction according to Metabolic Parameters.
|
Post operative delirium at 24 hours and 72 hours after surgery
Post operative Cognitive Dysfunction at 72 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
24/11/2023 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Post-Operative Delirium (POD) and Post- Operative Cognitive Dysfunction (POCD) are the common neurocognitive complications that observed in the elderly population after the surgery. The clinical features include deterioration in cognition such as agitation or confusion, during the days after surgery, disturbance in attention, reduced awareness of the environment and greater utilization of social financial assistance. The prevalence of POD and POCD are associated with higher mortality, increased incidence of postoperative complications and longer duration of hospital stay. In about 30-50% cases, even after delirium is resolved, elderly patients are additionally affected by post-operative cognitive dysfunction. Review articles revealed that postoperative delirium and postoperative cognitive dysfunction are multifactorial condition and has been elucidated on the molecular basis with diagnostic biological markers. Therefore, in this study we will assess the complete relation between metabolic disorder and the risk of postoperative delirium (POD) and postoperative cognitive dysfunction in elderly population. The identified biomarkers would be helpful in determining the severity and phase of the cognitive impairment to improve diagnosis and treatment of POD and POCD. |