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CTRI Number  CTRI/2025/10/096076 [Registered on: 14/10/2025] Trial Registered Prospectively
Last Modified On: 14/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective observational study 
Study Design  Single Arm Study 
Public Title of Study   A study to see whether yoga or physical exercise helps to improve memory and thinking in older adults undergoing major surgery 
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  NA 
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  Professor  
Affiliation  All India Institute of Medical Science (AIIMS), New Delhi.  
Address  Room No. 5008A, Main Building, teaching Block, Department of Anesthesiology, Pain Medicine and Critical care, AIIMS, Ansari Nagar, New Delhi

South West
DELHI
110029
India 
Phone  9873106516  
Fax    
Email  k.punit@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Puneet Khanna 
Designation  Professor  
Affiliation  All India Institute of Medical Science (AIIMS), New Delhi.  
Address  Room No. 5008A, Main Building, teaching Block, Department of Anesthesiology, Pain Medicine and Critical care, AIIMS, Ansari Nagar, New Delhi


DELHI
110029
India 
Phone  9873106516  
Fax    
Email  k.punit@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Puneet Khanna 
Designation  Professor  
Affiliation  All India Institute of Medical Science (AIIMS), New Delhi.  
Address  Room No. 5008A, Main Building, teaching Block, Department of Anesthesiology, Pain Medicine and Critical care, AIIMS, Ansari Nagar, New Delhi


DELHI
110029
India 
Phone  9873106516  
Fax    
Email  k.punit@yahoo.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi- 110029 
 
Primary Sponsor  
Name  Dr Puneet Khanna 
Address  Room No. 5008A, Main Building, teaching Block, Department of Anesthesiology, Pain Medicine and Critical care, AIIMS, Ansari Nagar, New Delhi  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NA  N/A 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Puneet Khanna   All India Institute of Medical Science (AIIMS), New Delhi.  Room No. 5008A, Main Building, teaching Block, Department of Anesthesiology, Pain Medicine and Critical care, AIIMS, Ansari Nagar, New Delhi
South West
DELHI 		 9873106516

k.punit@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Patients age above 60 years.
2.Undergoing major surgery under general anaesthesia.
3.ASA I and ASA II.
4.There is no minimum cognitive performance required to participate
5.Ability to give informed consent.
 
 
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   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
We anticipate to be able to justify the risk of postoperative delirium and postoperative cognitive dysfunction due to the metabolic syndrome.  The outcome will be assessed at four different
time points: 24 hours before surgery (baseline), 24 hours after surgery,
and 8 weeks after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
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)   01/12/2025 
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="3"
Months="0"
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  

This prospective observational study aims to investigate the association between Metabolic Syndrome (MetS) and the incidence of Post-Operative Delirium (POD) and Post-Operative Cognitive Dysfunction (POCD) in elderly patients (equal or greater than 60 years) undergoing major surgery under general anesthesia. POD and POCD are common neurocognitive complications in older adults after surgery and are associated with increased morbidity, mortality, and extended hospital stays (1). Although factors such as neuroinflammation and neurotransmitter imbalance have been linked to these conditions, the role of metabolic abnormalities remains inadequately explored (2). Metabolic Syndrome (MetS), characterized by hypertension, high blood sugar, elevated triglycerides, low HDL cholesterol, and central obesity, is widespread among the elderly and associated with cognitive decline (3). In this study, 100 patients will be evaluated for metabolic markers and undergo cognitive testing using DRS-R-98, Trail Making Test, and ACE-III both before and after surgery. The objective is to determine if Metabolic Syndrome (MetS)  is a significant predictor of POD and POCD. If a strong correlation is found, Metabolic Syndrome (MetS)  could be considered a modifiable risk factor, enabling targeted preoperative interventions (4). This may lead to improved perioperative risk assessment, better patient outcomes, and reduced healthcare burden. Ultimately, the study’s findings could contribute to developing preventive strategies for cognitive decline in elderly surgical patients.

References:

Vasilevskis EE, Han JH, Hughes CG, Ely EW. Epidemiology and risk factors for delirium across hospital settings. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):277– 87.

Feinkohl I, Janke J, Hadzidiakos D, et al. Associations of the metabolic syndrome and its components with cognitive impairment in older adults. BMC Geriatr 2019; 19: 77

Strachan MWJ, Reynolds RM, Frier BM, Mitchell RJ, Price JF. The relationship between type 2 diabetes and dementia. Br Med Bull 2008; 88: 131e46

Gregory, S. H., King, C. R., Abdallah, A. B., Kronzer, A., & Wildes, T. S. (2021). Abnormal preoperative cognitive screening in aged surgical patients: a retrospective cohort analysis. British journal of anaesthesia, 126(1), 230-237.

 
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