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CTRI Number  CTRI/2021/03/031769 [Registered on: 08/03/2021] Trial Registered Prospectively
Last Modified On: 07/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   An observational study to find how frailty affects delirium and cognitive decline in elderly patients undergoing spinal surgery under general anaesthesia 
Scientific Title of Study   Association between Pre-operative frailty and Post-Operative Delirium and Cognitive dysfunction in elderly patients undergoing spinal surgery under general anaesthesia : A Prospective Observational Study. 
Trial Acronym  FrailPodPocd 
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 Ward block All India institute of medical sciences Ansari nagar East New Delhi
100/A Sudarshan cinema road Gautam nagar New delhi
South
DELHI
110049
India 
Phone  9479818125  
Fax    
Email  anjaleekrishnak@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Puneet Khanna 
Designation  Associate Professor 
Affiliation  All India institute of medical sciences 
Address  Department of Anaesthesiology, Pain medicine and Critical care All India institute of medical sciences Ansari nagar East New Delhi

South
DELHI
110049
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 All India institute of medical sciences Ansari Nagar East New Delhi
100/A Sudarshan cinema road Gautam nagar New delhi
South
DELHI
110049
India 
Phone  9479818125  
Fax    
Email  anjaleekrishnak@gmail.com  
 
Source of Monetary or Material Support  
All India institute of medical sciences New Delhi 
 
Primary Sponsor  
Name  All India institute of medical sciences 
Address  Department of Anaesthesiology, Pain medicine and Critical care AIIMS 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  All India institute of medical sciences   Department of Anaesthesiology, Pain medicine and Critical care Ansari nagar East New 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 AIIMS New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age above 60 years.
2. Undergoing surgery under general anaesthesia
3. Can give informed consent themselves
4. There is no minimum cognitive performance required to participate.
 
 
ExclusionCriteria 
Details  1. 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 medication (eg:antidepressants, antipsychotics, sedatives)
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Post operative delirium  24 hours post surgery
72 hours post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative cognitive dysfunction  72 hours post surgery
 
Morbidity outcomes secondary to frailty  30 days post surgery 
 
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)   08/03/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   INTRODUCTION
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).
One of the most common pathologies seen in the aforementioned population is the presence of spinal conditions associated with both degenerative and traumatic pathologies. It has been observed from studies that there is a rise in the prevalence of degenerative spinal conditions with increasing age and that this is expected to rise with increase in population and life expectancy (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). 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.
This study aims at observing a correlation between presence of frailty in pre-operative period in the elderly Indian population undergoing orthopaedic 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.

HYPOTHESIS: Frailty in elderly population is associated with post-operative delirium and cognitive dysfunction.
PRIMARY OBJECTIVE :
To determine the association between pre-operative frailty in elderly patients undergoing spinal surgery under general anaesthesia with post-operative delirium.
SECONDARY OBJECTIVES:
1) To determine the association between pre-operative frailty in elderly patients undergoing spinal surgery under general anaesthesia with post-operative cognitive dysfunction.
2) To determine the association between sarcopenia in elderly patients undergoing spinal surgery under general anaesthesia with post-operative delirium.
3) To determine the association between sarcopenia in elderly patients undergoing spinal 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.



 
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