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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: F05||Delirium due to known physiological condition, |
|
Intervention / Comparator Agent
|
|
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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