Clinical Effect Observation of Lower Limb Warming Blanket Combined With Dexmedetomidine in Preventing Postoperative Delirium and Chills in Elderly Patients Undergoing Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Intraoperative vital signs monitoring
研究概览
简要总结
Objective: To observe the clinical effect of lower limb warming blanket combined with dexmedetomidine (DEX) in preventing postoperative delirium (POD) and chills in elderly patients undergoing spinal surgery. Methods: A total of 160 elderly patients undergoing posterior spinal surgery under general anesthesia were selected and divided into control group (group N), heating group (group T), DEX group (group D) and heating combined with DEX group (group TD) according to the random number table method, 40 cases in each group. T group and TD group routine insulation and lower limb heating blanket. DEX was injected in group D and group TD. The dosage of anesthetics, the changes of body temperature and heart rate at different time points during operation, and the occurrence of postoperative chills and POD were compared among the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: between 65-80 years old;
- •American Society of Anesthesiologists (ASA) grade II-III;
- •Normal body temperature before operation;
- •the operation time was 2-4 hours
排除标准
- •Preoperative fever or hypothermia (body temperature≥37.5 ℃ or≤35.5℃ on the day of operation);
- •Body mass index (BMI) >30 kg/m2;
- •The existence of heart, brain, lung, kidney and other important organs and circulatory system, respiratory system, immune system, central nervous system diseases;
- •Patients who had taken antipsychotic drugs or β-blockers before surgery would have a greater impact on intraoperative body temperature and other patients who could not effectively cooperate with this study;
- •Patients with operation time more than 5 hours
研究组 & 干预措施
heating group (group T)
干预措施: Lower limb heating blanket (Device)
DEX group (group D)
干预措施: Dexmetomidine (Drug)
heating combined with DEX group (group TD)
干预措施: Lower limb heating blanket (Device)
heating combined with DEX group (group TD)
干预措施: Dexmetomidine (Drug)
结局指标
主要结局
Intraoperative vital signs monitoring
时间窗: 3 hour
nasopharyngeal temperature
The incidence of postoperative chills
时间窗: 1 hour
chills refer to the Wrench classification criteria as follows : 0: no chills; grade 1: peripheral vascular contraction, vertical hair, but no muscle fibrillation; level 2: only one muscle group had muscle fibrillation; grade 3: muscle fibrillation in multiple groups; level 4: general tremor; ≥ 1 level was judged to have chills.
The incidence of POD after operation
时间窗: 1 day
The results of POD in each group were recorded, and the POD was evaluated by CAM-CR scale. The incidence of POD at 24,48 and 72 h after operation was compared among the groups
Postoperative extubation time
时间窗: 1 hour
The recovery time from the end of surgery to extubation was recorded.
Postoperative incision infection rate
时间窗: 1 hour
The incidence of postoperative incision infection was recorded.
次要结局
未报告次要终点
研究者
Wei Fan
Principal Investigator
Jincheng General Hospital