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临床试验/NCT02009007
NCT02009007Unknown1 期

Effect of Phenylephrine or Dopamine Infusion on Cerebral Oxygen Saturation in Thoracic Surgery Patients

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
50
试验地点
1
主要终点
Cerebral oximeter reading

研究概览

简要总结

Liberal fluid administration is one of risk factors of developing acute lung injury (ALI) in thoracic surgery. Therefore, the investigators try to restrain fluid administration, and in the case of intraoperative hypotension, the investigators often administer vasoactive agents or inotropes. One lung ventilation (OLV) which is routinely employed for thoracic surgery decrease arterial oxygenation and oxygen delivery to brain can be also decreased. In this study, the investigators compared dopamine and phenylephrine in respect to maintaining cerebral oxygen saturation in major thoracic surgery. The investigators hypothesis is that dopamine is better than phenylephrine to maintain cerebral oxygen saturation in thoracic surgery.

详细描述

A 'restrictive' intraoperative fluid regimen, avoiding hypovolaemia but limiting infusion to the minimum necessary reduced major complications after complex surgery. This restrictive fluid regimen is especially relevant in thoracic surgery since acute lung injury is known to be related to large amount of fluid administration during operation to treat hypotension. One study suggests that, for every 500-mL increase in perioperative fluids, there is an odds ratio of 1.17 for developing ALI after lung resection. Slinger suggested that fluid should be restricted just to the point of maintaining urine output of 0.5 mL/kg/h, and vasopressors may be used if tissue perfusion is inadequate. Therefore, restriction of fluid administration and treatment of hypotension which is not caused by major hemorrhage with vasoactive agents could be a basic concept in thoracic anesthesia.

Patients who undergoing lung resection surgery usually receive one lung ventilation (OLV). Decrease of systemic oxygenation occurs during OLV due to intrapulmonary shunt. During OLV, significant decrease in cerebral oxygenation (SctO2) is also known to occur and low SctO2 is related to postoperative complications.

Because the endpoint of hemodynamic optimization is to improve oxygen delivery to major organs, understanding how the administration of vasoactive agents affects cerebral perfusion and oxygenation, the most important organ in the body is of major clinical relevance. Recently published studies show that near-infrared spectroscopy (NIRS)-guided brain protection protocols might lead to reduced neurocognitive complications and improved postoperative outcomes.

However, there have been no data on which agent between dopamine and phenylephrine, the most commonly used aged during operation against hypotension, is better in maintaining cerebral oxygen saturation during thoracic surgery. Therefore, the investigators try to compare dopamine and phenylephrine continuous infusion in respect to maintaining SctO2 in major thoracic surgery.

In addition, acute kidney injury (AKI) develops in around 6% of patients after lung resection surgery and AKI is related to poor prognosis and prolonged duration of hospital admission.Therefore, the investigators also tried to find which agent is better to maintain urinary output during operation and reduce postoperative AKI. The investigators also found there is difference in postoperative delirium incidence between dopamine and phenylephrine continuous infusion.

研究设计

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

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective surgery
  • American society of anesthesia physical status I-III

排除标准

  • Symptomatic cardiovascular disease
  • Poorly controlled hypertension (systolic arterial pressure ≥160 mm Hg)
  • Cerebrovascular disease
  • Poorly controlled diabetes mellitus (blood glucose ≥200 mg/dl)
  • Diuretics or antidepressant use before operation
  • Renal insufficiency (creatinine>1.5 mg/dl)
  • Cerebral infarction
  • Documented coagulopathy

研究组 & 干预措施

dopamine

Experimental

dopamine is administered to maintain systolic blood pressure in the range of 80-120% of baseline during operation

干预措施: dopamine (Drug)

phenylephrine

Experimental

Phenylephrine is administered to maintain systolic blood pressure in the range of 80-120% of baseline during operation

干预措施: phenylephrine (Drug)

结局指标

主要结局

Cerebral oximeter reading

时间窗: at 60 minutes after one lung ventilation

次要结局

  • cardiac output(at 60 minutes after one lung ventilation)
  • incidence of delirium(participants will be followed for the first 48 hours of ICU stay)
  • incidence of acute renal injury(participants will be followed for the first 48 hours of ICU stay)

研究者

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

Hyun Joo Ahn

Associate professor

Samsung Medical Center

研究点 (1)

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