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临床试验/NCT01871935
NCT01871935Unknown不适用

Comparison of the Effects of Atropine on Haemodynamics and Tissue Oxygenation in Anaesthesia With Propofol and Sufentanil Versus Propofol and Remifentanil

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
70
试验地点
1
主要终点
CO

研究概览

简要总结

Induction of general anaesthesia with a combination of opiates and hypnotics often induces vasodilation resulting in several haemodynamic effects such as a decrease in blood pressure (MAP), heart rate (HR) and cardiac output (CO). This haemodynamic suppression may jeopardize tissue oxygenation, particularly cerebral oxygenation. Previous research of the investigators group has revealed that atropine has an exceptionally beneficial effect on the determinants of tissue oxygen delivery as well as on tissue oxygenation. The investigators have demonstrated a significant and clinically relevant increase in CO and cerebral tissue oxygenation (SctO2) for a desired increase in MAP. This is in steep contrast with the more usual clinical practice of administrating classical vasoactive medication such as phenylephrine or norepinephrine, since the two latter have an even negative effect on CO and SctO2. In previous research the investigators used standardized target controlled propofol/remifentanil infusions for induction and maintenance of anaesthesia. It is known that remifentanil has more intense haemodynamic side-effects compared to other opiates such as fentanyl, sufentanil or alfentanil. This raises the question whether the beneficial effect of atropine is restricted to propofol/remifentanil anaesthesia, or if this is equally valid during anaesthesia of propofol combined with other opiates such as sufentanil.

Patients undergoing off-pump coronary artery bypass grafting (CABG) require a long and deep general anaesthesia, which is usually performed with the combination of drugs as mentioned above. Because these patients often experience severe haemodynamic fluctuations they need to be closely monitored.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Age: 18 years and older.
  • Elective CABG surgery performed off-pump.
  • Written informed consent to participate in this study.
  • Patient and surgical procedure appropriate for treatment with either sufentanil or remifentanil.

排除标准

  • Refusal to participate in this study.
  • Age: younger than 18 years.
  • Pregnant.
  • BMI > 35 kg/m
  • Patients in which atropine is contra-indicated.
  • Patients in which sufentanil or remifentanil at the proposed doses are contra-indicated.
  • Urgent or emergency surgery.

研究组 & 干预措施

Remifentanil

Active Comparator

Anaesthesia with remifentanil/propofol

干预措施: Remifentanil (Drug)

Sufentanil

Active Comparator

Anaesthesia with sufentanil/propofol

干预措施: Sufentanil (Drug)

结局指标

主要结局

CO

时间窗: During anaesthesia

次要结局

  • Tissue oxygen saturation(During anaesthesia)
  • CO(During anaesthesia)
  • MAP(During anaesthesia)

研究者

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

A.F.Kalmar

MD, PhD

University Medical Center Groningen

研究点 (1)

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