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临床试验/NCT02840006
NCT02840006已完成4 期

Spinal Anesthesia Associated With General Anesthesia in Coronary Artery Bypass

Daniel Gioielli de Castilho4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
4
主要终点
consumption of fentanyl citrate in intra-operative in Coronary Artery Bypass Grafting surgery with cardiopulmonary bypass under spinal anesthesia associated with general anesthesia.

研究概览

简要总结

CONTEXT: In patients eligible for coronary artery bypass surgery, anesthesia should provide a number of conditions that exceed the limits of cardiovascular stability, myocardial protection and other organs. Moreover, the combination of general anesthesia and spinal anesthesia lessens the homeostatic, metabolic, hormonal and immunosuppressive changes. The goal of this research was to evaluate the consumption of fentanyl citrate in intra-operative in Coronary Artery Bypass Grafting (CABG) surgery with cardiopulmonary bypass under spinal anesthesia associated with general anesthesia.

METHODS: Clinical, prospective, randomized and double covered study, approved by the Research Ethics Committee. Fifty-six patients candidates for CABG with CPB, after signing the Terms of consent, were randomized and divided into two groups: GI - General and GII - General + subarachnoid. General anesthesia was induced according to the weight of each patient and maintenance with isoflurane and fentanyl. Spinal anesthesia was induced with 20 mg of 0.5% hyperbaric bupivacaine and 200 mcg of morphine, the patient is placed in cephalo-position slope of 45 degrees for 10 minutes in Group II. In the statistical study was performed using the Mann-Whitney test; the level of statistical significance was set at 5%.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

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 of both genders
  • Underwent cardiac artery bypass surgery with cardiopulmonary bypass, with
  • No restriction on age
  • No restriction on ethnicity
  • No restriction on education or social class

排除标准

  • Patients with sternotomy provided; those
  • Urgent surgery and/or emergency
  • Patient was with signs of shock
  • Patients with chronic renal failure
  • Patients with liver disorders
  • Tracheostomy patients
  • Patients with presence of use of mechanical ventilatory support;
  • Patients with physical disabilities; bedridden and wheelchair users.
  • Patients to withdraw the Consent and Informed
  • Patients who eventually had to be re-operated in the presence also of the mechanical ventilatory support.

结局指标

主要结局

consumption of fentanyl citrate in intra-operative in Coronary Artery Bypass Grafting surgery with cardiopulmonary bypass under spinal anesthesia associated with general anesthesia.

时间窗: in 24 hours

Will be measure the consumption of fentanyl in 24 hours

次要结局

未报告次要终点

研究者

发起方
Daniel Gioielli de Castilho
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daniel Gioielli de Castilho

MD

Universidade do Vale do Sapucai

研究点 (4)

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