The Effect of the Perioperative Blood Pressure on the Onset of Postoperative Cognitive Dysfunction in Adults
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
- 否
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
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
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
Dostalova Vlasta, MD, PhD
Dostalova Vlasta, MD, PhD
University Hospital Hradec Kralove
