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临床试验/NCT03846765
NCT03846765已完成4 期

Influence of Continuous Administration of Phenylephrine Versus Dobutamine on Spinal Oxygen Saturation, Measured With Near-infrared Spectroscopy (NIRS).

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2019年7月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
36
试验地点
1
主要终点
Spinal oxygen saturation measured by NIRS

研究概览

简要总结

To assess the effect of hemodynamic supportive medication on spinal vasculature, patients scheduled for arterial dilation of the lower limb were chosen as our study population. The spinal cord perfusion is not compromised in these patients, however, most patients suffer from hypotension during this kind of surgery, due to the non-invasive type of surgery and the vasodilating effects of the anesthetics. Therefore, continuous administration of vasoactive medication (phenylephrine or dobutamine) is often required in order to increase blood pressure.

The aim of our study is to evaluate the effect of a continuous administration of phenylephrine or dobutamine on the spinal oxygenation, assessed by NIRS.

详细描述

All patients receive standard anesthesia care during the surgical procedure. Before induction of anesthesia, baseline MAP will be defined and 6 additional sensors (stickers) will be applied to the back of the patient at three levels: 1 at the upper thoracic level(T3-T4), 2 at the lower thoracic level (T9-T10) and 2 at the lumbar region (L1-L2) and 1 on the deltoid muscle of the upper arm. Two sensors are routinely applied to the forehead to measure cerebral oxygenation and a BIS sensor is applied to measure depth of anesthesia. In all patients a non-invasive cardiac output monitor (Clearsight; EdwardsTM LifeScience, Irvine, CA, USA) is routinely used. This monitor provides a continuous arterial pressure waveform in a non-invasive way and facilitates continuous evaluation of blood pressure. Hereby, efficient adaptation of the administration of vasopressors is feasible. Through an intravenous line, anesthetics will be administered. Vasopressor agents will be administered through a dedicated second intravenous line. After induction of anesthesia, an endotracheal tube is placed.

A vasopressor agent will be administered continuously after intubation in order to maintain blood pressure in a range from MAPbaseline -20% to normal (preoperative) values (MAPbaseline). If MAP decreases to a value lower than MAPbaseline -20%, a higher dose of vasopressor will be administered. If MAP increases to a value above MAPbaseline, the dosing rate will be decreased. According to the group to which the patient has been randomized, phenylephrine or dobutamine will be administered and the dose will be adjusted to MAP during a 30-minute study period.

The total drug amount for phenylephrine and dobutamine will not exceed 5 mg, resp. 30 mg.

The study will be completed after 30 minutes of continuous medicamentous hemodynamic support administration (i.e. 30 minutes after intubation) or if administration of phenylephrine or dobutamine exceeds 1 µg/kg/min or 10 µg/kg/min, respectively.

If the administration of the study medication does not achieve the desired result, management of the hemodynamics will be left to the discretion of the attending anesthesiologist and the patient will be excluded from further data analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Patients ≥ 18y
  • Patient is scheduled for dilation of arterial blood vessels of the lower limb

排除标准

  • Age < 18y
  • BMI > 30
  • severe valvular disease
  • previous aortic surgery
  • paraplegia/ paraparesis
  • kidney replacement therapy
  • pacemaker
  • pregnancy
  • lactating participants
  • preoperative use of ACE inhibitors.
  • No sinus rhythm on preoperative ECG or at induction of anesthesia (patients with a history of atrial fibrillation can be included if they have a sinus rhythm on their preoperative ECG)

研究组 & 干预措施

Phenylephrine continuous infusion

Experimental

干预措施: Phenylephrine (Drug)

Dobutamine continuous infusion

Experimental

干预措施: Dobutamine (Drug)

结局指标

主要结局

Spinal oxygen saturation measured by NIRS

时间窗: from intubation until 30 minutes after intubation

Spinal oxygen saturation measured by NIRS

次要结局

  • Cerebral oxygen saturation(from intubation until 30 minutes after intubation)
  • Deltoid muscle oxygen saturation(from intubation until 30 minutes after intubation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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