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临床试验/NCT05721391
NCT05721391已完成不适用

To Study the Impact of Frailty on Postoperative Complications in Oncosurgeries

Rajiv Gandhi Cancer Institute & Research Center, India2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
To study incidence of postoperative complications in frail patients

研究概览

简要总结

Advanced ageing is accompanied by loss of reserve in multiple organ systems leading to increased risk of complications after surgery.Frailty is a functional syndrome involving reduced physiological reserve and 25-56% of all elderly surgical patients are reported to be frail .

详细描述

Patients above 65 years age undergoing major Oncosurgery under general anaesthesia with or without Epidural will included , written informed consent will be obtained from all patients. Age, Heigth , Weigth , polypharmacy , smoking status , history of Diabetes ,Hypertension will be noted. Basic investigation Hb% , Serum Albumin , Serum creatinine will be done. ASA Physical status and Surgical risk will be noted .Patients will be evaluated for Frieds 5 point Frailty Assessment Scale (i) Unintended weigth loss of > 5kg in last one year.(ii) self reported exhaustion, (iii) muscle weakness (grip strength) (iv)slow walking speed,(v) Low physical activity and assigned to either No Frail Group (0 criteria) , Pre-Frail (1-2 positive criteria ), Frail (3-5 positive criteria Group).The assessment will be done in the preoperative anaesthesia clinic and include paper based questionnaire, hand dynamometer to measure muscle strength and walking test .

All patients will receive standard general anaesthesia along with Epidural for Abdomino-pelvic surgeries.Intraoperative monitoring 5 lead ECG, NIBP/IBP , SPO2, ETCO2, CVP(Optional),BIS will be done.After induction of anaesthesia Ultrasonography will be performed with curvilinear probe --- at the midpoint of femur anteriorly to measure Rectus Femoris muscle thickness of Right thigh , three consecutive readings will be measured and average of value noted for all patients.

At the end of surgery patient's neuromuscular block will be reversed and trachea extubated , if any patient requires ventilator support note will be made accordingly. Postoperative patients vitals and Input/Output charting will be done .Postoperative analgesia either epidural analgesia or intravenous opioids according to Institutional protocol will be given .Length of ICU Stay and any major cardiac , respiratory , Renal complications , re-exploration will be noted.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing major onco-surgey

排除标准

  • Patient refusal to participate
  • Age <65 years.
  • Emergency surgery
  • Pre-existing dementia
  • Language barrier

结局指标

主要结局

To study incidence of postoperative complications in frail patients

时间窗: upto 7 days

Postoperative major complications as myocardial infarction, Respiratory failure, cerebrovascular event, renal failure , re-exploration will be noted and statistically analysed.

次要结局

  • Length of ICU stay(upto 240 hours.)

研究者

发起方
Rajiv Gandhi Cancer Institute & Research Center, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Anita Kulkarni

Principal investigator

Rajiv Gandhi Cancer Institute & Research Center, India

研究点 (2)

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