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CTRI Number  CTRI/2025/07/091214 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 18/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   An observational prospective study of risk factors and incidence of post-operative delirium in elderly patients undergoing non-cardiac surgery 
Scientific Title of Study   An observational prospective study of risk factors and incidence of post-operative delirium in elderly patients undergoing non-cardiac 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  Bharat Chavhan 
Designation  Junior Resident doctor in MD Anesthesiology. 
Affiliation  Lokmanya Tilak Municipal Medical College, Sion, Mumbai. 
Address  Department Of Anesthesiology, Lokmanya Tilak Municipal Medical College, Sion, Mumbai.

Mumbai
MAHARASHTRA
400022
India 
Phone  7798780837  
Fax    
Email  bharatchvan3131@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Hemangi Karnik 
Designation  Professor 
Affiliation  Lokmanya Tilak Municipal Medical College, Sion, Mumbai. 
Address  Department Of Anesthesiology, Lokmanya Tilak Municipal Medical College, Sion, Mumbai.

Mumbai
MAHARASHTRA
400022
India 
Phone  9324501900  
Fax    
Email  dr_hemangi@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Bharat Chavhan 
Designation  Junior Resident doctor in MD Anesthesiology. 
Affiliation  Lokmanya Tilak Municipal Medical College, Sion, Mumbai. 
Address  Department Of Anesthesiology, Lokmanya Tilak Municipal Medical College, Sion, Mumbai.

Mumbai
MAHARASHTRA
400022
India 
Phone  7798780837  
Fax    
Email  bharatchvan3131@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal Medical College and Hospital Sion Mumbai,400022, Maharastra,India. 
 
Primary Sponsor  
Name  Lokmanya Tilak Municipal College and Hospital Sion Mumbai 
Address  Department Of Anesthesiology, Lokmanya Tilak Municipal Medical College, Sion, Mumbai. 
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 Bharat Chavhan  Lokmanya Tilak Municipal Medical College.  Surgical Icu ,3rd Floor Lokmanya Tilak Municipal Medical College and Sion Hospital, Sion, Mumbai 400022
Mumbai
MAHARASHTRA 
7798780837

bharatchavan3131@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Human Research Lokmanya Tilak Municipal Medical College and General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R54||Age-related physical debility,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details 
1. Patients undergoing non cardiac surgery with age greater than 60 years
2. ASA I, II, III patients
 
 
ExclusionCriteria 
Details 
1. Patients less than 60 years.
2. Patients not willing to give consent.
3. Patients in whom assessment of delirium is not feasible due to any reason.
4. Patients with pre-existing cognitive dysfunction.
5. Patients who are likely to remain intubated after surgery.
6. Hemodynamically unstable patients.
7. Delirium occurred during preoperative assessment
8. Inability to read or understand the informed consent documents
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To study the incidence of post operative delirium in elderly patient
2. To study the association of risk factors preoperative comorbidities and disabilities with the post operative delirium in elderly patient.

 
at 1 hour after surgery and at24 hour after surgery.

 
 
Secondary Outcome  
Outcome  TimePoints 

1. To study the association of type of Anaesthesia and intraoperative complications with the post operative delirium in elderly patient.

 
at 1 hour post operatively and at 24hour post operatively 
 
Target Sample Size   Total Sample Size="225"
Sample Size from India="225" 
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)   31/07/2025 
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="1"
Months="0"
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  

.

Delirium is a disorder characterized by disturbances in consciousness, orientation, memory, thought, perception and behavior of acute onset and fluctuating course. Many with pre -existing dementia and appears to be independently associated with significant increase in functional disability, length of hospital stays, rates of admission to long term care institutions rate of death and healthcare cost. Despite its clinical importance delirium is often not detected or misdiagnosed as dementia or other psychiatric illness.

       Symptoms of the delirium develops over hours to days, although onset may be abrupt. Clouding of consciousness is cardinal feature of the delirium. There is reduced ability to focus, sustain or shift attention to external stimuli that may account for all other cognitive deficits. distractibility and decreased concentration follow from inability to focus or sustain attention. Abnormalities in the form and content of thinking are prominent. The organization and utilization of information are impaired. thinking may become illogical. Language functions are often abnormal. Speech may be tangential, circumstantial poorly organized, slow and slurred speech, word finding difficulties. There is disturbance in remote and recent memory. disorientation is most commonly manifested by mistakes in time, place and sometime person.

  Perceptual disturbances can occur like illusion or hallucination. visual, auditory are more common.  Psychomotor disturbances can occur.  In hyperactive delirium characterized by agitation, autonomic arousal, diaphoresis, tachycardia, dilated pupil, dry mouth.

   Delirium is a multifactorial in older patients. The multifactorial model for the etiology of delirium has been well validated and widely accepted. The development of delirium involves exposure to noxious insults or precipitating factors.

Neuroinflammation is one possible pathophysiological mechanism for post operative delirium. Systemic inflammatory mediators are significantly increased after surgery and remain high in post operative period. preclinical studies have shown that peripheral inflammation can lead to loss of structural and functional loss of blood brain barrier integrity, subsequently leading to translocation of inflammatory mediators and cells into CNS. This finally leads to loss of neuroplasticity.

It is reported that diseases that increase the risk of cerebrovascular events such as hypertension, atrial fibrillation and previous stroke are all risk factors for developing the post op delirium. radiological evidence cerebral ischemia can be seen in 7-10 percent of the elderly post -surgical patient and this associated with more than double the risk of post operative delirium. small cohort study of lung transplant patient showed that every 10 mm hg decrease in cerebral perfusion pressure is associated with double risk of post operative delirium.

  Polypharmacy is commonly associated with the advanced age and presence of multiple comorbidities both of which increases the post operative delirium. Polypharmacy itself is the independent risk factor for the development of the delirium in older population.  large number of medications are thought to directly increase the risk of delirium.

 prolonged fasting result in unnecessary use of the iv fluid and other perioperative complication such as nausea and vomiting.  A large cohort study found that fluid fasting more than 6 hours is the independent risk factor for the development of post operative delirium. Several observational studies have found that preoperative pain is associated with 1.5 to 3 times higher risk of postoperative delirium. Pain triggers acute stress response and increases the other post operative complication which may cause delirium. Surgical trauma can cause acute stress response and systemic inflammation. In additions higher incident of the postoperative delirium are mostly reported in association with the complex surgeries.

Predisposing factors for delirium

1.    Reduced cognitive reserve: dementia, depression, advanced age. Reduced physical reserve: atherosclerotic diseases, renal impairment, advanced age, preoperative beta blockade, alcohol abuse, malnutrition, dehydration, apolipoprotein e4 genotype

 

 

Precipitating factors for delirium

Medication or medication  withdrawal: Anticholinergics, muscle relaxant, antihistamines,  GI antispasmodics, opioid analgesics, Antiarrhythmic, corticosteroids, greater 6 total medication, greater than 3 new inpatient medication .hypoxemia, electrolyte abnormalities, malnutrition, dehydration, environmental changes such as  ICU admission ,Sleep wake cycle disturbance, urinary catheter use, restraint use, psychotropic medication use: antidepressant, antiepileptics, antipsychotics, benzodiazepines.                                                 

As it is increasingly evident that delirium is associated with poor outcome and increase health care costs, its timely diagnosis is crucial to prevent patients from developing severe long -lasting complications. Only a fraction of patient with delirium are quickly recognized by the caregivers. Those   patients usually present with hyperactive forms of the delirium commonly characterized by the agitation, restlessness, hallucination and delusion, In contrast the hypoactive form of delirium characterized by reduced    movements, paucity of speech and unresponsiveness can be misdiagnosed as the depression, anxiety or a calm and comfortable patient when proper screening is not performed. A rough distribution of the delirium presentation suggest that it may be of hyperactive forms percent hypoactive form percent, and mixed form 25 percent of cases. The more clinically silent hypoactive type may be associated with higher mortality that hyperactive types.

      As missing the diagnosis of delirium might have important negative consequences on outcome, clinicians should actively look for it; especially in high- risk patients, Screening must be performed in all vulnerable patients to minimize the impact of these conditions.

      In diagnosing delirium there are no definitive laboratory tests, and the differential diagnosis for acute abnormalities of cognition and attention are broad. A complete blood count, electrolyte panel, glucose measurement, arterial blood gas, urine analysis and electrocardiography should be considered in all patients with acute confusion to rule out correctable conditions like hypoxemia, hypoglycemia, and electrolyte imbalance .Life threatening organic condition like withdrawal syndromes [e.g. ethanol] and intracranial condition like meningitis, hypertensive crisis and status epilepticus should be given appropriate consideration. Imaging studies like chest radiography, computed tomography, or magnetic resonance imaging of head should be requested on the basis of clinical suspicion of specific pathologies such as stroke. Electroencephalography may show non -specific changes, particularly generalized slowing to theta delta range.

 

 
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