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临床试验/CTRI/2025/08/092468
CTRI/2025/08/092468尚未招募不适用

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.

NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年8月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
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:

研究概览

简要总结

•       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.

研究设计

研究类型
Observational

入排标准

年龄范围
60.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Surgery lasting more than 2 hours
  • Patients satisfying American Society of Anesthesiologist Class I ,II and III.

排除标准

  • 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.

结局指标

主要结局

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:

时间窗: The analysis of above two parameters by Ultrasound will be done in the pre operative room before the OT

1. Rectus femoris cross-sectional area (RF-CSA)

时间窗: The analysis of above two parameters by Ultrasound will be done in the pre operative room before the OT

2. Rectus femoris muscle thickness (RF-MT)

时间窗: The analysis of above two parameters by Ultrasound will be done in the pre operative room before the OT

次要结局

  • 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)

研究者

发起方
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Sourabh Vyas

NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital

研究点 (1)

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