跳至主要内容
临床试验/2025-520812-33-00
2025-520812-33-00招募中3 期

CARDIOPROTECTIVE-NEPHROPROTECTIVE EFFECTS OF SEVOFLURANE IN COMPARISON WITH PROPOFOL IN DOUBLE VALVE SURGERY. USE OF SEVOFLURANE AS A PILLAR OF PROTECTION IN EXTRACORPOREAL CIRCULATION AND POSTOPERATIVE SEDATION

Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年1月27日最近更新:
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
70
试验地点
1
主要终点
Evaluation variables: Sex, age, Cardiac index, creatinine, N-GAL, Stroke Volume index, heart rate, beats / min, mean arterial pressure, right ventricular end-diastolic pressure, Troponin I, NT-ProBNP, pre/postconditioning enzymes, renal dysfunction, inotropic support, days of ICU stay and circRNA values

研究概览

简要总结

To evaluate the effects of sevoflurane administration intra- (including the period of extracorporeal circulation ischemia) and postoperatively in patients undergoing double valve surgery with respect to propofol in terms of reducing myocardial damage and injury. For this, the levels of NT-ProBNP and troponin I will be measured; and its impact on myocardial preservation, through the measurement of the cardiac index intraoperatively and immediately postoperatively, as well as the use of inotropes for low cardiac output syndrome.

入排标准

年龄范围
18 years 至 65+ years(18-64 Years, 65+ Years)
接受健康志愿者

入选标准

  • Age ≥ 18 years.
  • Elective surgery cardiac surgery with double valve pump.
  • Use of Nido cardioplegia, common in this type of patient

排除标准

  • History of adverse reaction to sevoflurane or propofol.
  • Severe disease of any organ (lung, liver, kidney), diagnosed preoperatively.
  • Combined surgery (e.g. coronary or carotid surgery).
  • Patients in a situation of hemodynamic instability.
  • Heart failure or need to use inotropic or vasoactive drugs prior to the intervention.
  • Treatment with oral antidiabetics not suspended at least 48 hours before.
  • Treatment with euphylline/theophylline prior to the intervention.
  • Inability to grant informed consent.
  • Pregnancy or breastfeeding.

结局指标

主要结局

Evaluation variables: Sex, age, Cardiac index, creatinine, N-GAL, Stroke Volume index, heart rate, beats / min, mean arterial pressure, right ventricular end-diastolic pressure, Troponin I, NT-ProBNP, pre/postconditioning enzymes, renal dysfunction, inotropic support, days of ICU stay and circRNA values

Evaluation variables: Sex, age, Cardiac index, creatinine, N-GAL, Stroke Volume index, heart rate, beats / min, mean arterial pressure, right ventricular end-diastolic pressure, Troponin I, NT-ProBNP, pre/postconditioning enzymes, renal dysfunction, inotropic support, days of ICU stay and circRNA values

次要结局

未报告次要终点

研究者

申办方类型
Laboratory/Research/Testing facility
责任方
Principal Investigator
主要研究者

Elvira Bonilla

Scientific

Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

研究点 (1)

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