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临床试验/NCT01213602
NCT01213602已完成不适用

Bilateral Bispectral Index Changes During Knee Replacement Surgery With and Without Femoral Block

Hospital Universitari de Bellvitge1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
85
试验地点
1
主要终点
Sevoflurane requirements

研究概览

简要总结

The principal objective is to notice the relevance of timing performance of femoral block for knee replacement surgery during general anesthesia and analyze the relationship with bilateral bispectral index (BIS) monitoring during induction and maintenance of anesthesia. Otherwise the investigators try to investigate if the timing of performance of this block influence in postoperative variables as pain or blood loss.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • ASA IV, patients with difficult airway management, patients with antecedent of cerebral ischemia, presence of atrioventricular fistula, patients with absent distal pulses or history of vascular surgery in the involved limbs, patients with high risk of deep vein thrombosis.-

结局指标

主要结局

Sevoflurane requirements

时间窗: 6 months

Combined ( femoral block and general anesthesia) or balanced anesthesia ( intravenous analgesics and general anesthesia) is evaluated on the requirements of inhalational hypnotics during surgery. Schedule time when BIS has to be in proper range (40-60): T1 T2 T3 T4 T5 T6 T1 Induction T2 Inflated cuff ischemia T3 Incision T4 Unlocking cuff ischemia T5 End surgery T6 Time to wake the patient from the close of the sevoflurane vaporizer Each time include a period of adjustment in 5 minutes

次要结局

  • Intraoperative and postoperative opiates requirements and relations with CVI(Time surgery and 24,48 and 72 h postoperative)

研究者

发起方
Hospital Universitari de Bellvitge
申办方类型
Other

研究点 (1)

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