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CTRI Number  CTRI/2025/08/092468 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 05/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study to detect the association of preoperative ultrasound guided sarcopenia detection with postoperative morbidity in elderly patients undergoing major surgery 
Scientific Title of Study   Association of Sarcopenia Detected by Preoperative Point of Care Ultrasound of Rectus Femoris Muscle with Postoperative Morbidity in Elderly Patients Undergoing Major Surgery: A Prospective 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  Dr Sourabh Vyas 
Designation  Junior Resident Anaesthesiology 
Affiliation  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
Address  Department of Anaesthesiology, 4th floor, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  8888065245  
Fax    
Email  sourabhvyas19@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ketaki Marodkar 
Designation  Professor, Department of Anaesthesiology 
Affiliation  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
Address  Department of Anaesthesiology, 4th floor, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  9850967274  
Fax    
Email  drketaki_didolkar@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Sourabh Vyas 
Designation  Junior Resident Anaesthesiology 
Affiliation  N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
Address  Department of Anaesthesiology, 4th floor, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  8888065245  
Fax    
Email  sourabhvyas19@gmail.com  
 
Source of Monetary or Material Support  
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur, 440019 
 
Primary Sponsor  
Name  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
Address  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur 440019 
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 Sourabh Vyas  NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital  Department of Anaesthesiology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA 
8888065245

sourabhvyas19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Nagpur.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Surgery lasting more than 2 hours
2. Patients satisfying American Society of Anesthesiologist Class I ,II and III 
 
ExclusionCriteria 
Details  1.Pre existing cognitive dysfunction or delirium
2.Pre existing muscle disorder/weakness like muscular dystrophies
3.Extremity amputation
4.Pre-existing paralysis
5.Pre-existing soft tissue oedema
6.Unwilling to participate in study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find the proportion of sarcopenia detected by preoperative point of care ultrasound of rectus femoris muscle in elderly patients undergoing major surgery by measuring:
1. Rectus femoris cross-sectional area (RF-CSA)
2. Rectus femoris muscle thickness (RF-MT) 
The analysis of above two parameters by Ultrasound will be done in the pre operative room before the OT 
 
Secondary Outcome  
Outcome  TimePoints 
To find if there is an association between sarcopenia detected by preoperative point of care ultrasound of rectus femoris muscle & postoperative morbidity in elderly patients undergoing major surgery.  The relatives will be explained preoperatively about the morbidity parameters & the telephonic Montreal cognitive assessment scoring & then will be followed telephonically at the end of 1 month post surgery for the following parameters
Length of hospital stay more than 7 days
Readmission within 30 days
Ischemic cardiac event
ICU admission for ventilatory support
Presence of new-onset cognitive dysfunction as assessed by telephonic Montreal cognitive assessment scoring 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   20/08/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

       The population aged 65 years and over worldwide is predicted to reach 1.6 billion by year 2050. 

       ‘Frailty’, a recent concept in anesthesiology and peri-operative medicine, is defined as diminished physiological reserve predisposing to adverse outcomes when exposed to stressors.

       Sarcopenia’, defined as an age-related loss of muscle mass and muscle function is an important precursor of physical frailty, mobility limitation, and premature death and can be used as a non-subjective phenotypic marker of frailty.

       As there is an increasing number of older patients undergoing surgery, anesthesiologists will be faced with more frail patients in their daily work.

       Preoperative fasting, effects of anesthetic agents, intraoperative blood loss, postoperative pain, nausea and vomiting and immobility during the perioperative period are insults for an already frail body.

       Various questionnaire-based scales like Edmonton frailty scale, Fried phenotype5, PRISMA-7 ,Clinical frailty scale etc. are used for assessment of frailty but are subjective, tedious and time consuming.

       Imaging modalities like dual-energy x-ray absorptiometry, magnetic resonance imaging, computed tomography are currently an area of research to bridge the gap between clinical assessment scales and objective markers of frailty but are expensive and can not be performed bedside.

       Detection of sarcopenia using ultrasound which is a non invasive and comparatively cheaper method has recently gained popularity and protocols for the same have been updated in 2021.

       Sarcopenia affects predominantly lower limb muscles than upper limb  muscles and hence muscle thickness and cross sectional area of rectus femoris muscle which is superficial, easier to trace by ultrasound and significantly affected in frail patients have been chosen as sarcopenia detection parameters in our study.

       Therefore we have planned this study with an aim to know the proportion of sarcopenia detected by preoperative point of care ultrasound of rectus femoris muscle in elderly patients undergoing major surgery and its association with postoperative morbidity.

 
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