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临床试验/NCT04203290
NCT04203290已完成不适用

Comparison of General Anesthesia and Combined General Thoracic Epidural Anesthesia on End Tidal Volatile Anesthetic Concentration in Cases Which Depth of Anesthesia is Adjusted Using Entropy Monitoring; A Prospective Trial

Istanbul University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年12月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
End tidal volatile anesthetic concentration

研究概览

简要总结

The aim of this study is to adjust the end tidal inhalation anesthetic concentration by observing the entropy value in patients who will be provided anesthesia maintenance with volatile anesthetics after applying the routine epidural anesthesia technique and to observe the end tidal volatile concentration that will provide to remain in the target entropy limits during the operation.

详细描述

The hypothesis of this study is that in general anesthesia cases which is combined with thoracic epidural anesthesia (TEA), lower alveolar concentration will be required to reach the same anesthesia depth. The main aim of the study is observing and comparing the alveolar concentrations of anesthetic agents with entropy monitoring which is an anesthesia depth monitor in major abdominal surgeries where general anesthesia is combined or not with TEA.

In cases where TEA is combined with general anesthesia or not, anesthesia depth will be effectively monitored by entropy monitoring, in this way the adequate depth of anesthesia will be provided with the use of minimal volatile anesthetics and we will be able to prevent the use of large amounts of volatile anesthetics., It will be determined how much reduction in alveolar concentration is required in cases combined with TEA.

Nowadays, with the development of reliable anesthesia machines, "low-flow anesthesia" (LFA) is becoming more widespread, and its benefits on patient health, economy and ecology have been demonstrated. In LFA, the depth of anesthesia should not be too superficial or too deep during the time the alveolar concentration of volatile agent reaches equilibrium. Therefore, alveolar concentrations of volatile anesthetics are monitored in modern anesthesia machines. Some machines may also adjust the depth of anesthesia according to the alveolar concentration of the agent.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • undergoing major abdominal surgery
  • Patients who will not undergoing operation for thoracic cavity
  • Body Mass Index (BMI) between 20-30

排除标准

  • denial of patients
  • contraindications for thoracic epidural anesthesia
  • patients who are FEV1/FVC < 60
  • patients with thoracic and lomber vertebrae surgery

研究组 & 干预措施

General anesthesia

Active Comparator

Patients will be applyed 0.03 mg/kg midazolam, 2 mcg/kg fentanyl, propofol until reaching the appropriate anesthetic depth by observing entropy value (40-60) and 0.5 mg/kg rocuronium for anesthesia induction, after intubation sevoflurane will be used for anesthesia maintenance with low flow anesthesia (0.5 l/min).

干预措施: Sevoflurane (Drug)

General anesthesia combined with thoracic epidural anesthesia

Active Comparator

Before anesthesia induction epidural catheter will be inserted giving 7 ml bupivacaine %0.25 in saline + 50 mcg fentanyl after confirming the location of catheter, following 15 minutes the standard anesthesia induction will be applied ( 0.03 mg/kg midazolam, 2 mcg/kg fentanyl, propofol until reaching the appropriate anesthetic depth by observing entropy value (40-60) and 0.5 mg/kg rocuronium ). For anesthesia maintenance epidural infusion will be applied ( 7ml/h %0.25 bupivacaine solution) together with low flow (0.5 l/min) sevoflurane anesthesia.

干预措施: Bupivacaine (Drug)

General anesthesia combined with thoracic epidural anesthesia

Active Comparator

Before anesthesia induction epidural catheter will be inserted giving 7 ml bupivacaine %0.25 in saline + 50 mcg fentanyl after confirming the location of catheter, following 15 minutes the standard anesthesia induction will be applied ( 0.03 mg/kg midazolam, 2 mcg/kg fentanyl, propofol until reaching the appropriate anesthetic depth by observing entropy value (40-60) and 0.5 mg/kg rocuronium ). For anesthesia maintenance epidural infusion will be applied ( 7ml/h %0.25 bupivacaine solution) together with low flow (0.5 l/min) sevoflurane anesthesia.

干预措施: Sevoflurane (Drug)

结局指标

主要结局

End tidal volatile anesthetic concentration

时间窗: up to 20 minutes

End tidal volatile anesthetic concentration that keeps entropy in normal limits

次要结局

  • Total volatile anesthetic consumption(up to 2 hours)
  • Time to reach target concentration(up to 10 minutes)
  • Inhalation anesthetic amount the target concentration reached ( in the period of reaching the set alveolar concentration)(up to 5 minutes)
  • The amount of propofol(2 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nuzhet Mert Senturk, MD, Prof

Professor

Istanbul University

研究点 (1)

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