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CTRI Number  CTRI/2023/09/058047 [Registered on: 26/09/2023] Trial Registered Prospectively
Last Modified On: 23/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   cognitive screening of patients before anaesthesia to predict post operative confusion 
Scientific Title of Study   Pre-anaesthetic cognitive assessment as a tool to predict post-operative delirium in elderly patients - a prospective observational cohort 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  ARUN V 
Designation  JUNIOR RESIDENT 
Affiliation  K. S. HEGDE MEDICAL ACADEMY 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, K. S. HEGDE MEDICAL ACADEMY, DERALAKATTE, MANGALORE

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9895529700  
Fax    
Email  arunvasudevrajkumar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  JOYLIN DSOUZA 
Designation  ASSISTANT PROFESSOR 
Affiliation  K. S. HEGDE MEDICAL ACADEMY 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, K. S. HEGDE MEDICAL ACADEMY, DERALAKATTE, MANGALORE

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9901900185  
Fax    
Email  drjoysteff@gmail.com  
 
Details of Contact Person
Public Query
 
Name  JOYLIN DSOUZA 
Designation  ASSISTANT PROFESSOR 
Affiliation  K. S. HEGDE MEDICAL ACADEMY 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, K. S. HEGDE MEDICAL ACADEMY, DERALAKATTE, MANGALORE

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9901900185  
Fax    
Email  drjoysteff@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, K. S. HEGDE MEDICAL ACADEMY, DERALAKATTE, MANGALORE. 
 
Primary Sponsor  
Name  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, K. S. HEGDE MEDICAL ACADEMY 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, K. S. HEGDE MEDICAL ACADEMY, DERALAKATTE, MANGALORE  
Type of Sponsor  Private 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 
ARUN V  K. S. HEGDE MEDICAL ACADEMY  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, K. S. HEGDE MEDICAL ACADEMY, DERALAKATTE, MANGALORE
Dakshina Kannada
KARNATAKA 
9895529700

arunvasudevrajkumar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, K. S. HEGDE MEDICAL ACADEMY  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 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients undergoing elective surgery. 
 
ExclusionCriteria 
Details  Patients who are not willing to enroll for the study.
Patients with preexisting psychiatric illness.
Patients with preexisting dementia and known cognitive dysfunction.
Patients who are in the ICU.
Planned post-operative ICU admission.
Patients who won’t be able to perform MiniCog and HMSE test.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Detect undiagnosed cognitive impairment in elderly patients using MiniCog & HMSE.  During pre-anaesthetic evaluation on the day before surgery, study subjects will be given the MiniCog & HMSE tests. In the PACU, patients will be evaluated for level of arousal using the Richmond Agitation & Sedation Scale (RASS) and for delirium using Confusion Assessment Method (CAM). This will be done once the patient reaches an Aldrete score of more than or equal to 9, indicating appropriate level of wakefulness, hemodynamic and respiratory stability for discharge to wards. 
 
Secondary Outcome  
Outcome  TimePoints 
To determine whether patients with low MiniCog or HMSE scores in the pre-operative period are at higher risk of developing post-operative delirium.
To identify other factors which affect post-operative delirium. 
During pre-anaesthetic evaluation on the day before surgery, study subjects will be given the MiniCog & HMSE tests. In the PACU, patients will be evaluated for level of arousal using the Richmond Agitation & Sedation Scale (RASS) & for delirium using Confusion Assessment Method (CAM). This will be done once the patient reaches an Aldrete score of more than or equal to 9, indicating appropriate level of wakefulness, hemodynamic and respiratory stability for discharge to wards. 
 
Target Sample Size   Total Sample Size="117"
Sample Size from India="117" 
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)   16/10/2023 
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="1"
Months="6"
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  

After approval from the Institutional Ethics Committee, patients satisfying the inclusion criteria will be enrolled after obtaining informed written consent.

During pre-anaesthetic evaluation on the day before surgery, study subjects will be given the MiniCog screening test. The MiniCog consists of a 3-word registration and recall test for memory and a clock drawing test for distraction. The exam begins with asking the patient to repeat a list of three predetermined words. The patient is then asked to draw a clock and then recollect the three words. The maximum test score is 5, and points are deducted for each incorrect word recall or incorrect clock drawing. A MiniCog score ≤ 2 indicates probable cognitive impairment.

The patients will be evaluated using the HMSE scale in addition to the MiniCog. It is a reliable tool for assessing cognitive deterioration. HMSE score ≤23 indicates probable cognitive impairment.

 

 

In the PACU, patients will be evaluated for level of arousal using the Richmond Agitation and Sedation Scale (RASS) and for delirium using Confusion Assessment Method (CAM). This will be done once the patient reaches an Aldrete score of ≥9, indicating appropriate level of wakefulness, hemodynamic and respiratory stability for discharge to wards.22 CAM will be carried out twice, first on postoperative day zero and second on postoperative day one.

The RASS is a validated measure of arousal and level of consciousness, which has been shown to be effective in multiple clinical settings. The RASS is scored on a 10-point scale, with scores of 1–4 indicating increasingly high degrees of anxiety or agitation, a score of 0 indicating a calm and alert state, and scores between −1 and −5 indicating various levels of sedation, with −5 indicating that a patient is unarousable.

CAM is a validated measure of delirium that has been used in several hospital settings. The instrument addresses the following features: (1) acute onset or fluctuating course, (2) inattention, (3) disorganized thinking, and (4) altered level of consciousness. A positive diagnosis of delirium by the CAM requires the presence of features (1) and (2) and either (3) or (4).

Additional recorded data includes demographic characteristics (age, sex, education level), smoking or alcohol use, comorbidities, presence of sleep disturbances and visual or hearing impairment, ASA physical status, surgical specialty, duration of NPO, type of anaesthesia, intraoperative medications used, whether minimally invasive surgery or not and  duration of anaesthesia.

After evaluation with CAM, if patient is found to have delirium, any confounding factors detected will be addressed immediately and the patient will be managed as per the institutional protocols.

 
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