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临床试验/CTRI/2025/11/097980
CTRI/2025/11/097980尚未招募不适用

Change in energy expenditure normalized to fat free mass during general anesthesia in elderly and young adults.

Dr Rohit V1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月15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
30
试验地点
1
主要终点
Change in energy expenditure in relation to the fat free mass between elderly and young adults during general anaesthesia

研究概览

简要总结

Fat free mass will be measured using foot to foot bioimpedance analysis followed by standard preoperative investigations. The six minute walk test will be explained to each patient and separate consent will be obtained. The 6MWT is a simple practical test that measures the distance a patient can walk in six minutes on a flat hard surface reflecting submaximal functional capacity. It involves global physiological responses and allows for self paced walking making it suitable for assessing daily functional capacity. On the day of surgery standard monitors will be applied and anesthesia will be induced and maintained with propofol fentanyl and vecuronium. An endotracheal tube 7 or 8 mm ID will be used and mechanical ventilation will be set based on predicted body weight and endtidal CO2 between 35 and 40 mmHg. Minute ventilation will be calculated using the Holliday Segar formula. Depth of anesthesia during intubation will be maintained using propofol. Intraoperative monitoring will include temperature and low flow anesthesia of 500 mL per min will be initiated with sevoflurane to reach a minimum alveolar concentration of 0.8 supported by propofol until the desired MAC is achieved. Alarm limits will be set for ventilatory parameters. The following variables will be recorded every five minutes until the end of surgery namely MV temperature heart rate systolic blood pressure mean arterial pressure diastolic blood pressure end tidal oxygen fraction of inspired oxygen and EtCO2. Postoperatively patients will be observed in the post anesthesia care unit for at least one hour with rescue analgesia administered as 0.5 mcg per kg fentanyl if needed. Intraoperative opioid consumption blood loss and fluid requirements will be documented. Relevant time points such as post induction incision and end of surgery will be noted. Energy expenditure will be calculated using Weirs equation.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 15 patients aged 20 to 40 years of either sex and 15 patients aged more than 65years belonging to ASA status I, II, scheduled for non-laparoscopic urological and gynaecological surgeries will be recruited.

排除标准

  • 21-64 years ASA III BMI more than 35 kg per m2 Respiratory pathologies Beta blockers Musculoskelatal pathologies/ Patients with difficulty in ambulation Difficult airway.

结局指标

主要结局

Change in energy expenditure in relation to the fat free mass between elderly and young adults during general anaesthesia

时间窗: Every 5 minutes post-intubation intraoperatively

次要结局

  • Change in energy consumption with temperature between elderly and young adults during general anaesthesia(Preoperative and 2 hours after completion of surgery)

研究者

发起方
Dr Rohit V
申办方类型
Other [individual]
责任方
Principal Investigator
主要研究者

Dr Rohit V

Sri Ramachandra Institute of Higher Education and Research

研究点 (1)

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