Atropine Effects in Anaesthesia With Sufentanil vs. Remifentanil
Comparison of the Effects of Atropine on Haemodynamics and Tissue Oxygenation in Anaesthesia With Propofol and Sufentanil Versus Propofol and Remifentanil
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.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Groningen、荷兰、9713GZ
- 招聘中
- University Medical Center Groningen
-
接触:
- rob spanjersberg
- 邮箱:r.spanjersberg@umcg.nl
-
首席研究员:
- Alain F Kalmar, MD, PhD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Refusal to participate in this study.
- Age: younger than 18 years.
- Pregnant.
- BMI > 35 kg/m2.
- Patients in which atropine is contra-indicated.
- Patients in which sufentanil or remifentanil at the proposed doses are contra-indicated.
- Urgent or emergency surgery.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Remifentanil
Anaesthesia with remifentanil/propofol
|
Anaesthesia with remifentanil/propofol.
|
|
有源比较器:Sufentanil
Anaesthesia with sufentanil/propofol
|
Anaesthesia with sufentanil/propofol
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
CO
大体时间:During anaesthesia
|
During anaesthesia
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
MAP
大体时间:During anaesthesia
|
During anaesthesia
|
|
|
Tissue oxygen saturation
大体时间:During anaesthesia
|
During anaesthesia
|
|
|
CO
大体时间:During anaesthesia
|
CO obtained by different devices/methods (i.e. the Vigileo device and TEE)
|
During anaesthesia
|
合作者和调查者
调查人员
- 首席研究员:Alain F Kalmar, MD, PhD、University Medical Center Groningen
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.