| 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
|
|
|
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
|
|
|
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. |