Spinal Versus General Anesthesia on Postoperative Pulmonary Complications in Elderly Patients With Delayed Operation of Hip Fracture
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Arterial partial pressure of oxygen, PaO2
研究概览
简要总结
The objective of this study was to investigate the difference in postoperative pulmonary complications (PPCs) between spinal anesthesia and general anesthesia in patients undergoing delayed hip surgery.
详细描述
In this study, the difference of 30 min arterial partial pressure of oxygen after operation was used as the main outcome index. By means of pulmonary ultrasound, pulmonary function monitoring and other physical and biochemical examinations, the difference of postoperative pulmonary complications between spinal anesthesia and general anesthesia in patients with delayed operation of hip fracture longer than 48 hours was compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 65 years old
- •ASA Class I ~ III
- •Surgical repair of femoral neck, intertrochanteric or subtrochanteric fractures
- •The time from diagnosis to surgery is more than 48 hours
排除标准
- •Unable to walk about 3 meters or across a room without assistance before the fracture
- •Emergency surgery
- •Congestive heart failure, asthma, anemia (Hb < 90 g/L), hypoalbuminemia (ALB < 35g/L)
- •Abnormal coagulation function
- •Severe aortic stenosis
- •Injection site infection or increased intracranial pressure
- •Patients have participated in previous trials or have been determined by a surgeon or anesthesiologist to be unsuitable for randomization
- •The written informed consent of the patient or his/her representative cannot be obtained
研究组 & 干预措施
spinal anesthesia
Patients underwent real-time ultrasound guided spinal anesthesia. The maximum attempts of skin piercings are 3, and the total redirections of each skin piercings should not exceed 6 times. General anesthesia was considered if three skin piercings were unsuccessful.
干预措施: spinal anesthesia (Procedure)
general anesthesia
Rapid sequential induction was performed with sufentanil 0.5 ug /kg, etomidate 0.3 mg /kg, cisatracurium 0.15 mg /kg, and then laryngeal mask was applyed. Parameter settings: tidal volume: 6-10 mL/kg, 1.5 ~ 2.0% sevoflurane inhalation, remifentanil 0.1 ~ 0.2 ug/ kg.min-1. Mechanical driving pressure was applyed by PEEP titration method.
干预措施: general anesthesia (Procedure)
结局指标
主要结局
Arterial partial pressure of oxygen, PaO2
时间窗: 30 minutes after surgery
PaO2 was measured by arterial blood gas analysis
次要结局
- Forced vital capacity, FVC(30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery)
- Peak expiratory flow, PEF(30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery)
- Lung Ultrasound Score (LUS)(30 minutes before surgery, 30 minutes after surgery, 24 hours after surgery)
- Postoperative pulmonary complications(up to one month)
- Arterial partial pressure of oxygen, PaO2(30 minutes before surgery)
- Forced expiratory volume in 1 second, FEV1(30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery)
- PEF 25, 75, and 25-75(30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery)
- Hip mobility (Harris hip score, HHS)(up to one month)