Effect of Nasal Spray Dexmedetomidine on Emergence Delirium Prevention in Total Hip Replacement in the Elderly Under General Anesthesia: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- emergency delirium
研究概览
简要总结
Emergence Delirium (ED) is a common postoperative complication refers to an acute brain dysfunction that occurs during the recovery from general anesthesia, which is mainly characterized by sudden attention and consciousness disorders. The occurrence of ED increases the risk of self-injury, wound dehiscence, accidental catheter dislocation, and postoperative delirium, and is also associated with postoperative cognitive deterioration and increased utilization of medical resources after discharge.
详细描述
The incidence of hip fracture after surgery in patients over 55 years old is about 45%, and ED is highly predictive of delirium during postoperative hospitalization, which occurs in about 1/3 of ED patients during postoperative hospitalization.
It has been suggested that if delirium is monitored only on the first postoperative day and not at the PACU stage, up to 53% of delirium cases may be missed.
Studies have shown that perioperative application of dexmedetomidine can reduce the risk of postoperative delirium to a certain extent. However, intravenous dexmedetomidine usually leads to problems with delayed extubation, residual sedation, and prolonged PACU stay.
Previous studies have shown that intranasal dexmedetomidine improves perioperative sleep quality and neurocognitive deficits in elderly patients undergoing laparoscopic gynecologic surgery. Compared with intravenous administration, intranasal administration of dexmedetomidine resulted in milder hemodynamic fluctuations. However, stable nasal spray bioavailability is superior to intravenous dosage forms for nasal use.
Based on the above background, this study aims to investigate the effect of nasal spray of dexmedetomidine on the prevention of emergence delirium after total hip replacement in elderly patients.
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
- 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
- •Age ≥60 years old
- •Total hip arthroplasty under general anesthesia
- •Informed consent was obtained from patients or their guardians
排除标准
- •Allergy or contraindication to dexmedetomidine
- •Severe rhinitis and nasal deformity
- •Severe bradycardia (heart rate <50 beats/minute) or atrioventricular block of grade 2 or higher, permanent pacemaker implantation, severe heart failure or ejection fraction <30%
- •Patients with previous myocardial infarction, unstable angina pectoris, severe arrhythmia, and cardiac insufficiency
- •Emergency surgery
- •Severe hepatic and renal dysfunction (Child-Pugh class B and C, CKD3-5)
- •Preoperative mental illness, cognitive impairment, and communication difficulties could not be evaluated in the study
- •Preoperative delirium was present
研究组 & 干预措施
Dex group
at least 20 min before the introduction of anesthesia, the patient takes the sitting position, the head is slightly tilted forward, and the product is kept upright. Insert the nostril at the same Angle as the nasal cavity. Press down on the spray pump evenly with the index and middle fingers at the same time, and press the pump to the bottom at one time for 1 spray (25ug). After 1 spray on both nostrils, tilt your head back slightly and inhale gently. After staying for about 30 s, 1 spray was applied to each nostril on both sides for a total of 4 sprays (100ug).
干预措施: Nasal spray dexmedetomidine (Drug)
Saline group
Normal saline packaged in the same appearance was used
干预措施: Nasal spray dexmedetomidine (Drug)
结局指标
主要结局
emergency delirium
时间窗: postoperative
RASS\&CAM-ICU, delirium was judged according to whether there were positive features in the questionnaire
次要结局
- Preoperative anxiety score(preoperative)
- time to extubation(postoperative 3 days)
- PACU stay(postoperative 3 days)
- Postoperative delirium(postoperative 3 days)
- Hemodynamic changes(introperative)
- PONV(postoperative 3 days)
- sleep quality(postoperative 3 days)
- Pain score(postoperative 3 days)