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CTRI Number  CTRI/2021/08/036082 [Registered on: 31/08/2021] Trial Registered Prospectively
Last Modified On: 27/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   study to know the relation between frailty in elderly patients undergoing major surgery and delirium and cognitive decline post operatively 
Scientific Title of Study   Association between Pre-operative frailty and Post Operative Delirium and Cognitive dysfunction in elderly patients undergoing major surgery under general anaesthesia : Prospective Observational Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjaleekrishna K 
Designation  junior resident  
Affiliation  all india institute of medical sciences  
Address  department of Anaesthesiology,pain medicine and critical care fifth floor academic block AIIMS Sri Aurobindo Marg ansari nagar east new delhi

South
DELHI
110029
India 
Phone  9479818125  
Fax    
Email  anjaleekrishnak@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Puneet Khanna 
Designation  Associate Professor  
Affiliation  all india institute of medical sciences  
Address  AIIMS Sri Aurobindo Marg ansari nagar east new delhi

South
DELHI
110029
India 
Phone  9873106516  
Fax    
Email  k.punit@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Anjaleekrishna K 
Designation  junior resident  
Affiliation  all india institute of medical sciences  
Address  Department of Anaesthesiology, Pain medicine and Critical care fifth floor academic block AIIMS Sri Aurobindo Marg ansari nagar east new delhi

South
DELHI
110029
India 
Phone  9479818125  
Fax    
Email  anjaleekrishnak@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
 
Primary Sponsor  
Name  ALL INDIA INSTITUTE OF MEDICAL SCIENCES  
Address  ALL INDIA INSTITUTE OF MEDICAL SCIENCES SRI AUROBINDO MARG ANSARI NAGAR EAST NEW DELHI  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR ANJALEEKRISHNA  AIIMS NEW DELHI  AB8 Main OT complex 8th floor Ward block Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
South
DELHI 
9479818125

anjaleekrishnak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  55.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Age above 55 years.
2. Undergoing major surgery over 60 minutes
3. Can give informed consent themselves
4. Minimum cognitive performance required to participate is ACE-III score more than 88. 
 
ExclusionCriteria 
Details  Patients with a history suggestive of dementia (either listed in the medical record or
reported by the patient) or any neurological disorder.

2. History of alcohol abuse, chronic opioid or other substance abuse
3. History of cerebral surgeries, stroke.
4. History suggestive of psychiatric disease like schizophrenia, dementia, anxiety or other
disorder affecting cognition, mental dysfunction
5. Prescription of central nervous system–active medications (eg:antidepressants,
antipsychotics, sedatives) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
presence of post-operative delirium  24 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1) To determine the association between pre-operative frailty in elderly patients undergoing
surgery under general anaesthesia with post-operative cognitive dysfunction.
2) To determine the association between sarcopenia in elderly patients undergoing surgery under
general anaesthesia with post-operative delirium.
3) To determine the association between sarcopenia in elderly patients undergoing surgery under
general anaesthesia with post-operative cognitive dysfunction.
4) To determine the correlation between sarcopenia and post-operative morbidity and mortality.
5) To compare the discriminative ability of modified frailty index and ASA classification to
predict morbidity and mortality. 
72 HOURS POST SURGERY
30 DAYS POST SURGERY 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/09/2021 
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    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
With advances in medical care and technology, the world is currently facing a growth in the
aging population of above 60 years of age seen as a 56% rise from 901 million to a projected 1.4
billion between 2015 and 2030 (1), which is in turn associated with a rise in the comorbidities
associated with the same. In India, compared to 1951 national survey when elderly population
was 5.4%, there has been an increase up to 7.4% in the 2001 national survey. This rising trend
seen in the average life span of the population is inadvertently associated with increase in
incidence of pathologies and hence, demand for surgical procedures to manage them which in
turn pushes health care system to deal with expectant comorbidities of old age to begin with in
all these cases(2). It has been studied that a significant proportion of previously cognitively well
patients undergoing surgery and anaesthesia have been developing symptoms of cognitive
dysfunction after their procedure (34). This could be linked to the identification of surgery as an
iatrogenic stress-generating condition with far reaching effects on patient care, morbidity, care
giver stress and the dependent population burden on the society at large(3).
As we talk about the different comorbidities, elderly population is associated with risk of frailty
and sarcopenia. Frailty is a geriatric syndrome rendering the patient more vulnerable to any kind
of stressors and poor homeostatic reserve (4). Due to increased vulnerability to stress, physical
frailty describes the impact of medical comorbidities on a patient’s overall state of health. In
2001, Fried et al defined frailty by the presence of three or more of the following criteria:
unintentional weight loss, weakness as measured by grip strength, self-reported exhaustion, slow
walking speed and low physical activity level. Sarcopenia is defined as loss of skeletal muscle
and strength which causes age-related functional and physical impairment. It is featured by a

poor hand grip strength and slow walking pace. The similarity in the features associated with
both frailty and sarcopenia reflects in their similar association with poor outcomes post-surgery
like increased length of hospital stay, higher 30-day readmission rates and mortality(5).
Of the various morbidities noticed in elderly individuals after surgery, delirium, defined as
disturbance in attention and awareness that develops over a short period of time, typically
evolves within 72 hours following surgery(6,7,8). Mild Cognitive Impairment (MCI) converts to
dementia at a rate of 10% per year and has been linked with both delirium and POCD(35).
Makary et al. showed that preoperative frailty using the Fried criteria was associated with
increased risk for postoperative complications for patients undergoing cardiac surgery like a
higher risk of postoperative delirium (POD). POD is the most common postsurgical complication
in older adults and occurs in 14%–60% of older surgical patients (9) with an incidence ranging
from 5 to 51% in major surgeries(10). The incidence of POD in elderly patients after total joint
arthroplasty differs significantly among reports, ranging from 10% to 70% (11,12).
In about 30-50% cases, even after delirium is resolved, elderly patients are additionally affected
by post-operative cognitive dysfunction (POCD) (13). Other than as sequelae to post-operative
delirium, it can independently occur after surgeries up to 3 months. POCD refers to deterioration
in cognition temporally associated with surgery as quantified by neurophysiological tests. Its
incidence among patients older than 65 years is about 25.8% at ne week and 9.9% at three
months following surgery (14).
Although aetiology of both these are not completely understood, a multicausal association of
neuroinflammation, brain network dysfunction, endocrine stress response and neurotransmitter
imbalance is described in literature (15). Frailty has been found to have strong association with

post-operative delirium (POD), and to a lesser extent with cognitive dysfunction (POCD)(16).
However there is no established data regarding the same in non-cardiac surgery in Indian
population.
Since detection of MCI can be difficult, this study aims at observing a correlation between
presence of frailty in pre-operative period in the elderly Indian population undergoing all major
surgeries with the occurrence of delirium and cognitive dysfunction in the post-operative period.
We also try to determine if the presence of frailty and sarcopenia is associated with increased
incidence of postoperative morbidity such as cardiac, pulmonary, renal complications, deep vein
thrombosis, surgical site infection, length of hospital stay, length of ICU stay, readmission rates
and mortality rates.
 
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