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CTRI Number  CTRI/2021/07/035005 [Registered on: 20/07/2021] Trial Registered Prospectively
Last Modified On: 19/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study DOS Scale as a tool to predict development of postoperative delirium in elderly population 
Scientific Title of Study   Delirium Observation Screening (DOS) Scale as a preoperative predictive tool for development of postoperative delirium in elderly. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shikha Gupta 
Designation  Professor Anaesthesia 
Affiliation  Dayanand Medical College and Hospital (Baba farid university of health sciences) 
Address  Department of Anaesthesia, Dayanand Medical College and Hospital Civil lines Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  9814820622  
Fax    
Email  shikhadmc@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rushal 
Designation  PG Resident Anaesthesia 
Affiliation  Baba farid university of health sciences faridkot 
Address  Department of Anaesthesia, Dayanand Medical College and Hospital Civil lines Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  9988190699  
Fax    
Email  rushaln.95@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rushal 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital (Baba farid university of health sciences) 
Address  Department of Anaesthesia, Dayanand Medical College and Hospital Civil lines Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  9988190699  
Fax    
Email  rushaln.95@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital, Ludhiana 
 
Primary Sponsor  
Name  Dayanand Medical College and Hospital 
Address  Tagore Nagar, Civil lines , Ludhiana 
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 
Dr Shikha Gupta  DMCH Ludhiana  Department of Anaesthesia, DMCH, Tagore Nagar, Civil Lines, Ludhiana
Ludhiana
PUNJAB 		 9814820622

shikhadmc@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethical Committee DMCH Ludhiana  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  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  ASA I, II, III
Elderly (>60 yrs)age group
Elective procedures under regional anaesthesia (neuraxial anesthesia or peripheral nerve blocks)
 
 
ExclusionCriteria 
Details  History of Neurological Illness i.e. epilepsy, parkinsonism, brain injury or neurosurgery.
History of diseases such as schizophrenia, bipolar disorder, dementia, mania, depression, compulsive disorders.
Inability to comprehend English, Hindi or Punjabi language
Refusal to participate in the study
Patients on Neuroleptic or antipsychotic medications (Fluphenazine, Haloperidol, Aripiprazole, Clozapine, Olanzapine, Quetiapine, Risperidone, Benzodiazepines, Barbiturates, Chlorpromazine, etc.)
History of Drug Dependence
History of surgery in previous 6 months
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To calculate the incidence and prevalence of pre and postoperative delirium in elderly patients undergoing noncardiac surgery under regional anaesthesia.  a total of 100 elderly patients (age group 60 years undergoing noncardiac surgeries under regional anaesthesia will be assessed with MMSE and DOS scale for delirium preoperatively at the time of pre-anaesthesia checkup one day prior to surgery and then postoperatively after shifting the patient to the recovery room, 24 and 48 hours after surgery. The scores of the MMSE and DOS scale at the respective time intervals will be measured and recorded 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the efficacy of MMSE scale and DOS scale as a predictive tool for the detection of postoperative delirium in elderly.
To compare the change in the severity levels of delirium postoperatively from preoperative levels in patients with preoperative delirium.
 		 a total of 100 elderly patients (age group 60 years undergoing noncardiac surgeries under regional anaesthesia will be assessed with MMSE and DOS scale for delirium preoperatively at the time of pre-anaesthesia checkup one day prior to surgery and then postoperatively after shifting the patient to the recovery room, 24 and 48 hours after surgery. The scores of the MMSE and DOS scale at the respective time intervals will be measured and recorded 
 
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)   26/07/2021 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rushaln.95@gmail.com].

  6. For how long will this data be available start date provided 15-07-2021 and end date provided 15-07-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A randomized observational study will be conducted in the department of Anaesthesia, DMCH Ludhiana on a total of 100 elderly patients (age group >60 yrs) undergoing noncardiac surgeries under regional anaesthesia. They will be assessed with DOs scale and MMSE scale for delirium postoperatively at the time of shifting patient to the recovery room, 24hrs and 48hrs after the surgery.
The scores of MMSE and DOS at each time interval will be recorded as primary outcome of the study.
 
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