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临床试验/CTRI/2017/07/009039
CTRI/2017/07/009039招募中不适用

Effectiveness of forced air warming and infusion of high dose of amino acid solution on intraoperative hypothermia and coagulation dysfunction in patients undergoing head and neck cancer surgeries: A prospective randomized non-inferiority study

AIIMS NEW DELHI1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年7月17日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
1.Core temperature during general anaesthesia in patients undergo major oncological surgeries under general anaesthesia.

研究概览

简要总结

Induction of anaesthesia isuniversally associated with hypothermia due to loss of normal thermoregulatorymechanism. This rapid fall in core temperature during first hour is followed bya gradual and constant decline in core temperature. Even mild hypothermia maybe deleterious to the patient outcome because of associated myocardial ischemia,4 prolonged drug actions, 5 coagulopathy6 andshivering.  So we decided to conduct thisstudy to compare the effects of external heating (forced air warming system)and internal heat generation (amino acid infusion) in preventing hypothermiaduring anesthesia.

After institutional research committee’sapproval this prospective, randomized, study will be conducted in 75ASA Grade –I/II patients of either sex in the age group of 20 to 65 years admitted forelective cancer surgery under general anesthesia. The patients will berandomized into two  groups GroupAA4      (N=50): Amino Acid infusion @ 4ml/kg/hrand Group FA (N=50): forced air warming system will be applied. All the patients will be covered with the drapes. Intravenousfluids via fluid warmer will be given as per requirement.   All the patients will be hooked tostandard monitors in the operating room and anesthesia will be induced withPropofol 2mg/kg. Airway will be secured after injection vecuronium bromide(0.1mg/kg). The core temperature of the patients will be recorded pre inductionand every 20 minutes thereafter. OT temperature, meanintraoperative temperature, presence of intraoperative hypothermia, operativetime, use of blood products, total fluids infused, platelet and coagulationfunction  as assessed bythrombo-elastograph and oxygen debt will be noted. The data thuscollected will be expressed as a number or mean ± standard deviation. Patientcharacteristics will be compared with chi-squaretest. Appropriate tests will be applied for other data and the degree ofhypothermia will be correlated with various variables.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 100 ASA Grade – I/II patients admitted for major oncological surgeries under general anaesthesia will be included in the study.

排除标准

  • Those posted for emergency surgery
  • With known hepatic disease
  • Who had renal disease
  • With known or clinical hypothyroidism or hyperthyroidism
  • With known allergy to drugs used in the study •With BMI < 20 kg/m2 OR > 30kg/m2.

结局指标

主要结局

1.Core temperature during general anaesthesia in patients undergo major oncological surgeries under general anaesthesia.

时间窗: pre induction and every 10 minutes thereafter

次要结局

  • Platelet and coagulation pathway as tested by thromo-elastography.
  • Higher dose of AA and FA on perioperative blood loss

研究者

发起方
AIIMS NEW DELHI
申办方类型
Government medical college

研究点 (1)

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