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临床试验/NCT02536885
NCT02536885已完成不适用

The Effect of the Perioperative Blood Pressure on the Onset of Postoperative Cognitive Dysfunction in Adults

University Hospital Hradec Kralove2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Change in cognitive behavior

研究概览

简要总结

Permanent and temporary cognitive impairment in the perioperative period is of great importance to patients. Hypoperfusion due to the intraoperative hypotension is often mentioned as a possible cause of postoperative cognitive dysfunction.

详细描述

All patients aged above 60 years undergoing planned spinal surgery in the prone position in the duration of 1-3 hours under general anesthesia will be included in the study. In group L (liberal), the value of blood pressure will be corrected with the change of mean arterial pressure (MAP) ± 25% patient's mean arterial pressure, and group R (restrictive) with the change of MAP ± 10%. Cognitive dysfunction tests will be executed on the day before the surgery, two hours after the surgery and on the third postoperative day. Anesthesia will be managed according to the standardised protocol. Concentration of desflurane will be adjusted according to entropy values (target 40-50). Analgetics will be applied according to surgical pleth index (SPI) values. Sufentanil will not be applied in the last 15 minutes. Extubation will be performed at the operating theatre when meeting all extubation criteria including train of four ratio (TOFR) above 92%. Neither syntophyllin, nor pharmacological decurarization (syntostigmin) will be applied to the patients.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • ASA risk I - III
  • planned spinal surgery in the prone position
  • duration of the procedure of 1-3 hours

排除标准

  • hypertension above 180/100 torr preoperatively
  • blood pressure below 130/80 torr preoperatively

研究组 & 干预措施

Liberal group

Experimental

During the surgery, blood pressure of the patients will be maintained within ± 25% of the patient's normal blood pressure.

干预措施: Liberal group (Procedure)

Restrictive group

Experimental

During the surgery, blood pressure of the patients will be maintained within ± 10% of the patient's normal blood pressure.

干预措施: Restrictive group (Procedure)

结局指标

主要结局

Change in cognitive behavior

时间窗: within the first 3 days after surgery

measured by Addenbrooks cognitive test

次要结局

未报告次要终点

研究者

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

Dostalova Vlasta, MD, PhD

Dostalova Vlasta, MD, PhD

University Hospital Hradec Kralove

研究点 (2)

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