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CTRI Number  CTRI/2023/06/054562 [Registered on: 30/06/2023] Trial Registered Prospectively
Last Modified On: 25/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Frailty in patients undergoing anesthesia 
Scientific Title of Study   FrailtyIndex as a predictor of perioperative outcomes in elderly patients undergoing elective surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NABITHA VARGHESE 
Designation  JUNIOR RESIDENT 
Affiliation  St John’s medical college hospital  
Address  ST JOHNS MEDICAL COLLEGE HOSPITAL ,SARJAPUR ROAD BANGALORE
Dept of anaesthesiology ,second floor ot complex St John’s medical college hospital,Sarjapur road Bangalore -560034
Bangalore
KARNATAKA
560034
India 
Phone  8095138185  
Fax    
Email  nabithavarghese1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Moses charles 
Designation  Professor  
Affiliation  HOD,Professor, Surgical Intensive Care Unit, St Johns Medical college ,  
Address  Dept of Anesthesiology second floor OT complex St johns medical College
Surgical Intensive Care Unit St Johns Medical college Sarjapur road ,Bangalore
Bangalore
KARNATAKA
560034
India 
Phone  7829000524  
Fax    
Email  moses.cd@stjohns.in  
 
Details of Contact Person
Public Query
 
Name  Moses Charles  
Designation  Professor  
Affiliation  HOD,Professor, Surgical Intensive Care Unit, St Johns Medical college ,  
Address  ST JOHNS MEDICAL COLLEGE HOSPITAL ,SARJAPUR ROAD BANGALORE
Surgical Intensive Care Unit .St johns medical college Sarjapur Road Bangalore
Bangalore
KARNATAKA
560034
India 
Phone  7829000524  
Fax    
Email  moses.cd@stjohns.in  
 
Source of Monetary or Material Support  
Dept of anaesthesiology,second floor ot complex St John’s medical college Sarjapur Road Bangalore-560034 
 
Primary Sponsor  
Name  Nabitha varghese 
Address  Dept of anaesthesiology,second floor ot complex St John’s medical college Sarjapur Road bangalore 
Type of Sponsor  Other [self] 
 
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 
nabitha varghese  st johns medical college hospital  Department of anaesthesiology second floor ot complex St John’s medical college Sarjapur Road Bangalore
Bangalore
KARNATAKA 
8095138185

nabithavarghese1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committeeSt Johns Medical College Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  Elective surgery 
 
ExclusionCriteria 
Details  Cardiac Surgeries
Emergency SUrgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of frailty index among people undergoing elective surgeries   To follow up patients in pre op area ,monitor intra op and post op for 30min  
 
Secondary Outcome  
Outcome  TimePoints 
To find relation between frailty index & peri op outcomes   To monitor patients preop ,intra op,post op for 30minutes 
 
Target Sample Size   Total Sample Size="155"
Sample Size from India="155" 
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)   10/07/2023 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

With the advancements in modern medicine, life expectancy in Southeast Asia has increased dramatically during  the20th century.The  elderly population in low to middle-income countries has been predicted to increase more than three times compared to higher -income countries between 2010 and 2050.Due to an increase in the aging demographic, surgeons are more likely to operate on these patients with up to 30% of invasive procedures performed during the final year of life.A hospitalized older surgical patient is faced with many challenges during their phases of perioperative period. Apart from surgery there are many factors which can cause a huge impact on their frail body systems which includes fasting,intraoperative blood loss,anesthetic drugs,opioid analgesics,post operative nausea and vomiting ,hospital environment and immobility during perioperative period. Frailty is a frequent and  underdiagnosed functional syndrome involving reduced physiological reserves and an increased vulnerability against stressors, with severe individual and socioeconomic consequences.A routine frailty assessment during preoperative anaesthesia assessment can help identify patients at risk.

 
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