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临床试验/NCT06053398
NCT06053398已完成早期 1 期

Vasopressor Outcomes in Spine Surgery

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2023年11月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
101
试验地点
1
主要终点
Vasopressor requirement

研究概览

简要总结

This is a prospective, randomized control trial comparing norepinephrine versus phenylephrine for vasopressor support in patients undergoing elective spinal fusion surgery.

详细描述

There is limited evidence on the difference in postoperative outcomes between the choices of vasopressors used to treat intraoperative hypotension (IOH) in patients undergoing non-cardiac surgery under general anesthesia. A recent pilot feasibility trial comparing norepinephrine and phenylephrine for first-line intravenous infusion of vasopressor during general anesthesia and major non-cardiac surgery was unable to show any difference in postoperative outcomes. Although the study demonstrated safety and feasibility, it was not powered to detect differences in postoperative outcomes. The impact of vasopressors on postoperative outcomes in patients undergoing complex spinal surgery in the prone position is even scarcer. While it has been demonstrated that the use of intra-operative vasopressor infusion is safe and well tolerated, without any adverse renal outcomes, it is unclear if the choice of vasopressor makes any difference. While animal studies have shown that norepinephrine may provide greater spinal cord protection than phenylephrine, clinical studies in humans are lacking. We aim to fill this gap in knowledge by carrying out a prospective, randomized control trial to evaluate differential outcomes related to the choice of norepinephrine versus phenylephrine as the preferential vasopressor in patients undergoing elective spinal fusion surgery in the prone position.

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
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 > 18 years undergoing elective, prone, spinal fusion surgery

排除标准

  • Age < 18 years
  • Emergency surgery
  • Outpatient surgery
  • Pregnancy
  • End-stage renal disease requiring dialysis
  • Diagnosed myocardial ischemia and/or cardiac revascularization within the past month

研究组 & 干预措施

Phenylephrine

Active Comparator

Patients receiving phenylephrine for intraoperative hypotension

干预措施: Phenylephrine (Drug)

Norepinephrine

Active Comparator

Patients receiving norepinephrine for intraoperative hypotension

干预措施: Norepinephrine (Drug)

结局指标

主要结局

Vasopressor requirement

时间窗: During inpatient admission

Total intraoperative vasopressor requirement

次要结局

  • Postoperative Myocardial Injury(During inpatient admission)
  • Postoperative Lactate Elevation(During inpatient admission)
  • 30-day readmission(30-days post-discharge)
  • Postoperative acute kidney injury(During inpatient admission)
  • Intraoperative transfusion requirement(During inpatient admission)
  • Postoperative vasopressor requirement(During inpatient admission)
  • Length of ICU stay(During inpatient admission)
  • Length of hospital stay(From admission to discharge (up to 100 weeks))

研究者

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

Siddharth Dave

Assistant Professor

University of Texas Southwestern Medical Center

研究点 (1)

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