Adding Intra-articular Dexmedetomidine to Levobupivacaine for Postoperative Analgesia in Arthroscopic Knee Surgery
Phase 4 Study of Intra-articular Dexmedetomidine Adding to Levobupivacaine for Postoperative Analgesia in Arthroscopic Knee Surgery
研究概览
详细说明
Patients between 18-65 years and with American Society of Anesthesiologists' (ASA) Physical Status class I-II, who were scheduled for arthroscopic knee surgery, were enrolled in a randomised comparative clinical trial. Blinding or masking began in the preoperative holding unit. Exclusion criteria were psychiatric illness, younger than 18 yo, who has analgesic treatment before the surgery and known hypersensitivity to relevant drugs. All patients received a standard anaesthetic protocol; ECG, heart rate, non-invasive blood pressure, oxygen saturation and temperature were monitored. After preoxygenation, general anaesthesia was induced with sodium pentothal 4 to 7 mg/kg, 1 mcg/kg fentanyl and neuromuscular block was achieved with rocuronium 0.5 mg/kg and trachea was intubated. Anesthesia was maintained with desflurane 6% and 50% oxygen in the medical air.
Randomised patients were achieved dexmedetomidine and levobupivacaine or levobupivacaine intra-articularly 10 minutes before medical tourniquet deaerated.
Postoperative analgesia was maintained with morphine in patient-controlled analgesia. Patients postoperative VAS values and analgesic consumptions were recorded in postoperative 24 hours.
研究类型
注册 (实际的)
阶段
- 第四阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- older than 18 yo
- scheduled for arthroscopic knee surgery
Exclusion Criteria:
- younger than 18 yo
- known allergy relevant drugs
- contraindication for general anesthesia
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Levobupivacaine
Intraarticular 19 ml 0.5% levobupivacaine and 1 ml 0.9% sodium chloride administered.
postoperative morphine administered for analgesia
|
intraarticular
其他名称:
intraarticular 1 ml (100 mcg)
其他名称:
intravenously, patient-controlled analgesia
其他名称:
|
|
有源比较器:Dexmedetomidine
Intraarticular 19 ml 0.5% levobupivacaine and 1 ml (100 mcg/ml) dexmedetomidine administered, postoperative morphine used for analgesia
|
intraarticular 1 ml (100 mcg)
其他名称:
intravenously, patient-controlled analgesia
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Analgesic consumption
大体时间:up to 48 hours
|
up to 48 hours
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
blood pressure
大体时间:before deaerate the medical tourniquet, after deaerate the tourniquet, postoperative 0, 30, 60, 90, 120 minutes ,in the PACU, 4, 6, 12, 24, 48 hours
|
before deaerate the medical tourniquet, after deaerate the tourniquet, postoperative 0, 30, 60, 90, 120 minutes ,in the PACU, 4, 6, 12, 24, 48 hours
|
|
heart rate
大体时间:before deaerate the medical tourniquet, after deaerate the tourniquet, postoperative 0, 30, 60, 90, 120 minutes ,in the PACU, 4, 6, 12, 24, 48 hours
|
before deaerate the medical tourniquet, after deaerate the tourniquet, postoperative 0, 30, 60, 90, 120 minutes ,in the PACU, 4, 6, 12, 24, 48 hours
|
|
Visual Analog Scale-rest
大体时间:postoperative 0, 30, 60, 90, 120 minutes in the PACU, 4, 6, 12, 24, 48 hours
|
postoperative 0, 30, 60, 90, 120 minutes in the PACU, 4, 6, 12, 24, 48 hours
|
|
Visual Analog Scale-movement
大体时间:postoperative 0, 30, 60, 90, 120 minutes ,in the PACU, 4, 6, 12, 24, 48 hours
|
postoperative 0, 30, 60, 90, 120 minutes ,in the PACU, 4, 6, 12, 24, 48 hours
|
合作者和调查者
调查人员
- 首席研究员:Resul Altuntas, MD、TC Erciyes University
- 研究主任:Ayse Ulgey, Ast Prof、TC Erciyes University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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