Prospective, Randomized Comparative Study of Intravenous Dexmedetomidine for Sedation in Orthopedic Surgery Under Regional Anesthesia
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative analgesia duration
研究概览
简要总结
60 patients ASA I-III, undergoing orthopedic surgery will be randomly assigned into one of three groups, namely group A (n=20), where dexmedetomidine will be used for sedation (initial bolus dose followed by continuous infusion), group B (n=20) where midazolam will be used for sedation (initial bolus dose followed by continuous infusion) and group C (n=20), where remifentanil will be used for sedation (initial bolus dose followed by continuous infusion). All patients will receive spinal anesthesia. Duration of postoperative analgesia, total dose of patient controlled IV morphine, sedation scores, nausea and vomiting, time of ambulation, sleep quality and patient satisfaction will be recorded for the first postoperative day. Additionally chronic pain on the site of surgery will be recorded in 3 and 6 months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physical status according to American Society of Anesthesiologists (ASA) I-III Patients scheduled for orthopedic surgery
排除标准
- •Patient denial, contraindication of spinal anesthesia or any of the agents used in the protocol, BMI above 30, Serious psychiatric, mental and cognitive disorders, Language barrier, illicit substances abuse,
研究组 & 干预措施
Group A
Dexmedetomidine sedation
干预措施: Dexmedetomidine (Drug)
Group B
Midazolam sedation
干预措施: Midazolam (Drug)
Group C
Remifentanil sedation
干预措施: Remifentanil (Drug)
结局指标
主要结局
Postoperative analgesia duration
时间窗: 24 hours
Time of first demand for analgesia (PCA first bolus dose)
次要结局
- Sedation(24 hours)
- Postoperative pain: Numerical Rating Scale (NRS)(24 hours)
- Morphine consumption(24 hours)
- Rescue analgesia(24 hours)
- Complications(24 hours)
- Chronic pain: Graded Chronic Pain Scale (GCPS)(6 months)
- Delirium occurence(24 hours)
研究者
Alexandros Makris
Consultant Anesthesiologist
Asklepieion Voulas General Hospital