Hypotensive Effect of Anaesthesia With TCI (HEAT)
The Effect of Target Controlled Infusion as Opposed to Velocity Controlled Infusion on Hypotension at Induction of Total Intravenous Anaesthesia
研究概览
详细说明
Severe hypotension may be a serious complication to induction of anaesthesia. The patients preoperative clinical circulatory status will help define the risks of such a side-effect. A patient with a preexisting heart condition will be at increased risk for morbidity/mortality in relation to anaesthesia induction.
Total intravenous anaesthesia may be delivered by two different approaches. The old way where the drug (Propofol and/or Remifentanil) is delivered in a velocity (mg/kg x hour or microg/ kg x min) specified by the anaesthetist. Hereafter called Velocity Controlled Infusion (VCI). At induction, to get effect of the drug, a high infusion rate is desired. A high infusion rate is associated with increased risks of hypotension if it is not adjusted in accordance with the current circulatory status of the patient. A failure to adjust may be futile for the patient. Therefore, induction takes some time because infusion rate is set within a relatively safe range. After a few minutes, once airway control is achieved, the infusion rate must be adjusted down to avoid hypotension.
There is a more modern way of adjusting the infusion rate, the so called Target Controlled Infusion. With this approach, the pump delivering the drug will help the anaesthetist to select the appropriate infusion rate for any given situation. The anaesthetist selects a preferred concentration of the drug at the target, that is in the circulation. The pump then administrates the drug, first at high rate and then at lower rate, taking into account the patients age, weight and sex and the preferred target concentration.
It is possible that this help from the machine is associated with less risk for hypotension at anaesthesia induction. If this is so it would have an impact on which of TCI and VCI that would be the best choice of anaesthesia. This would have special impact when giving anaesthesia to patients with a heart condition.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Alberta
-
Östersund、Alberta、瑞典、83183
- Östersund Hospital
-
-
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:
* All patients scheduled for anaesthesia at Östersunds Hospital
- ASA class I-II
Exclusion Criteria:
- On beforehand decision to start continous delivery of blood pressure increasing drug at induction.
- Any contraindication to Total Intravenous Anaesthesia
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:Target Controlled Infusion
This group of patients will have their anaesthesia induced with Target Controlled Infusion (TCI)
|
|
|
其他:Velocity Controlled Infusion
This group of patients will have their anaesthesia induced with Velocity Controlled Infusion (VCI)
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hypotension
大体时间:20 minutes
|
Relative maximal decrease of blood pressure (in mmHg) by anaesthesia induction (%)
|
20 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pharmacological measures to increase blood pressure
大体时间:20 minutes
|
Number of doses of drug to increase blood pressure
|
20 minutes
|
|
Drug consumption
大体时间:From the start of anaesthesia induction to the time of airway control (Laryngeal airway working in place of tracheal tube working in place).
|
Amount (milligram) of Propofol delivered and amount (mikrogram) of Remifentanil delivered.
|
From the start of anaesthesia induction to the time of airway control (Laryngeal airway working in place of tracheal tube working in place).
|
|
PONV (Postoperative Nausea and Vomiting)
大体时间:From end of anaesthesia to 2 hours or when leaving the PostAnaesthesia Care Unit
|
Dose and name of any drug given to reduce PONV at any time defined above (in addition to profylaxis with the same aim)
|
From end of anaesthesia to 2 hours or when leaving the PostAnaesthesia Care Unit
|
合作者和调查者
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 (实际的)
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 (实际的)
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.