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CTRI Number  CTRI/2018/07/015125 [Registered on: 30/07/2018] Trial Registered Retrospectively
Last Modified On: 11/04/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   Acutely disturbed state of mind(Delirium)after operation(Surgery)  
Scientific Title of Study   Occurrence of postoperative delirium in patients undergoing elective surgeries under general anesthesia  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Javed Khan 
Designation  PG Anesthesiology 
Affiliation  LHMC DELHI 
Address  DEPARTMENT OF ANESTHESIOLOGY, LHMC, SMT. S.K.HOSPITAL, C-604, Shaheed Bhagat Singh Road, Diz Area, Connaught Place, New Delhi, 110001

Central
DELHI
110001
India 
Phone  9013834635  
Fax    
Email  drjkhallim@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Usha Saha 
Designation  Director Professor Anesthesia 
Affiliation  LHMC DELHI 
Address  C-604, Shaheed Bhagat Singh Road, Diz Area, Connaught Place, New Delhi, Delhi 110001

Central
DELHI
110001
India 
Phone  9810982588  
Fax    
Email  usha_shivsaha@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Usha Saha 
Designation  Director Professor Anesthesia 
Affiliation  LHMC DELHI 
Address  C-604, Shaheed Bhagat Singh Road, Diz Area, Connaught Place, New Delhi, Delhi 110001

Central
DELHI
110001
India 
Phone  9810982588  
Fax    
Email  usha_shivsaha@yahoo.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF ANESTHESIOLOGY, LHMC, SMT. S.K.HOSPITAL, C-604, Shaheed Bhagat Singh Road, Diz Area, Connaught Place, New Delhi, 110001 
 
Primary Sponsor  
Name  LHMC DELHI 
Address  C-604, Shaheed Bhagat Singh Road, Diz Area, Connaught Place, New Delhi, Delhi 110001 
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 JAVED KHAN  LHMC, SMT. S.K.HOSPITAL  Department of Anesthesiology ,Main Operation Theatre, C-604, Shaheed Bhagat Singh Road, Diz Area, Connaught Place, New Delhi, Delhi 110001
Central
DELHI 
9013834635

drjkhallim@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee For Human Research, LHMC and Associated Hospitals New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  All Patients planned for Elective Surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients 20-60 years of age, of either sex.
Elective surgeries under general anesthesia.
Elective surgeries under general anesthesia + Regional/Local anesthesia.
 
 
ExclusionCriteria 
Details  Age < 20 and > 60 years
Emergency surgeries
Thoracic/Cardiac/Obstetric/Orthopedic/Neurosurgery
Sole Regional anesthesia/Local anesthesia
Patients requiring postoperative ventilatory support
Pre-existing neuropsychiatric disorder (seizures, Space occupying lesion(SOL), head injury)
Patients on antipsychotic drugs and drug or alcohol abuse.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of postoperative delirium in patients undergoing elective surgeries under general anesthesia.
 
Confusion Assessment Method (CAM) applied preoperatively , and postoperatively at 2 hours, days 1, 2 and 3. VAS score (0-100 scale) used to assess pain at all times of observation. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Relationship between postoperative delirium and preoperative cognitive status.
2. Relationship between postoperative delirium and intraoperative factors (hemodynamic changes, blood transfusions, duration of anesthesia) and postoperative pain scores. 
Post operative Day3 follow up  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "128"
Final Enrollment numbers achieved (India)="128" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/10/2016 
Date of Study Completion (India) 01/03/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   "none yet" 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Delirium is a common problem in hospitalized patients, with a prevalence of 10-24% in medical population, 37–46% in surgical population, and upto 87% in ICU patients. In individuals over 65 years of age, hospitalized for medical conditions, approximately 10% exhibit delirium on admission, and another 10-15% may develop delirium while in hospital (DSM IV 1994).In Indian population, Rudraetal(2006)recorded 15% incidence of delirium in elderly patients after major elective surgeries.

Delirium is an acute and fluctuating disturbance of consciousness with reduced ability to focus, maintain, or shift attention, accompanied by change in cognition and perceptual disturbances, along with psychomotor, emotional and sleep-wake cycle disturbances.

Delirium is not a disease, but is a symptom of many pathological conditions, such as increasing age, dementia, infections, tumors, chronic diseases, metabolic disorders, fever, and intoxication. Post-operative delirium(POD) manifests in patients who have undergone surgical procedures and anesthesia, usually peaking within three days. Most recover within 4 weeks, but in 50% cases it may persist longer.      Incidence of  POD varies with patients age, pain scores, type of surgery, degree of operative stress, low pre-operative executive scores and depression. POD is a serious complication, associated with increased hospital and ICU length of stay, functional decline, high medical cost, 10 fold  increased risk of dementia, post-discharge institutionalization and death. Mortality increases by 10–20% for every 48 hours of delirium, chiefly from association with other postoperative complications. In literature, most studies are in elderly patients and very few in the young adult population.                                                                 Hence, we decided to carry out this study for occurrence of POD in patients 20-60 years age, and identify risk factors that may help in early diagnosis of Delirium and avoidance of POD. 

 
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