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临床试验/NCT06425627
NCT06425627招募中不适用

Spinal Versus General Anesthesia on Postoperative Pulmonary Complications in Elderly Patients With Delayed Operation of Hip Fracture

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月12日最近更新:
适应症

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

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

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)

研究者

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

Tianzhu Liu

M.D.

Tongji Hospital

研究点 (1)

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