Effect of the Deep Neuromuscular Block on Postoperative Delirium in Elderly Patients Undergoing Lumbar Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Delirium by CAM-ICU
研究概览
简要总结
The effect of deep neuromuscular blockade (NMB) during spine surgery reduced postoperative pain and bleeding in recent studies. Therefore by reducing these two factors, which were the contributing factors for postoperative delirium, deep NMB is expected to reduce the postoperative delirium. This study was designed to determine whether the deep NMB lowered the incidence of delirium after lumbar surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 70 and more;
- •Scheduled for an elective lumbar spine surgery;
- •ASA physical status 1-3
排除标准
- •Diagnosed neuromuscular disorder;
- •Contraindications to the study drug, e. g. known allergy or hypersensitivity, hypotension, bradycardia, higher grade atrioventricular block;
- •Patient with pre-existing cognitive impairment or dementia
研究组 & 干预措施
Deep NMB
A TOF count of 0, and a PTC of 1 to 3 will be maintained, as close to 2 twitches as possible
干预措施: Rocuronium for deep NMB (Drug)
Moderate NMB
A TOF count of 1 to 3 will be maintained, as close to 2 twitches as possible
干预措施: Rocuronium for moderate NMB (Drug)
结局指标
主要结局
Delirium by CAM-ICU
时间窗: from just after surgery at the PACU to post-operative 5 days
Occurrence of delirium assessed by CAM-ICU during the post-operative 5 days
次要结局
- Intramuscular pressure(intraoperative)
- Peak inspiratory airway pressure(intraoperative)
研究者
Seok Kyeong Oh
Assistant Professor
Korea University Guro Hospital