| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
|
|
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. |