The Effect of Target Controlled Infusion as Opposed to Velocity Controlled Infusion on Hypotension at Induction of Total Intravenous Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Hypotension
研究概览
简要总结
Hypotension will often complicate induction of anaesthesia. The investigators want to test the hypothesis that Target Controlled Infusion, as opposed to Velocity Controlled Infusion, leads to less degree of hypotension.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* All patients scheduled for anaesthesia at Östersunds Hospital
- •ASA class I-II
排除标准
- •On beforehand decision to start continous delivery of blood pressure increasing drug at induction.
- •Any contraindication to Total Intravenous Anaesthesia
研究组 & 干预措施
Target Controlled Infusion
This group of patients will have their anaesthesia induced with Target Controlled Infusion (TCI)
干预措施: Target Controlled Infusion (Other)
Velocity Controlled Infusion
This group of patients will have their anaesthesia induced with Velocity Controlled Infusion (VCI)
干预措施: Velocity Controlled Infusion (Other)
结局指标
主要结局
Hypotension
时间窗: 20 minutes
Relative maximal decrease of blood pressure (in mmHg) by anaesthesia induction (%)
次要结局
- PONV (Postoperative Nausea and Vomiting)(From end of anaesthesia to 2 hours or when leaving the PostAnaesthesia Care Unit)
- Drug consumption(From the start of anaesthesia induction to the time of airway control (Laryngeal airway working in place of tracheal tube working in place).)
- Pharmacological measures to increase blood pressure(20 minutes)
研究者
Joakim Johansson
Dr Joakim Johansson
Umeå University