Patient-controlled Sedation Versus Target-controlled Infusion in Orthopaedic Surgery Under Central Neuraxial Block
Propofol Sedation in Orthopaedic Surgery Under Central Neuraxial Block: Patient-controlled Sedation Versus Target-controlled Infusion
研究概览
详细说明
Central neuraxial block (CNB) is one of the mainstays of anaesthesia methods in various disciplines particularly orthopaedic surgeries. However the state of consciousness can potentially cause patient anxiety thus sedation is often utilized as a mean to improve patient satisfaction and increase patient acceptance of CNB.
Conventionally, the anaesthesiologist administers sedatives for the patients. Propofol is the commonly used drug for sedation due to its favourable pharmacokinetic profile, which results in fast induction, easy control of depth of sedation and rapid recovery. It can be infused by using target-controlled infusion (TCI) devices where the anaesthetists titrates propofol by setting desired target plasma and effect site concentration. However it is difficult to judge precisely patient requirements for adequate patient sedation, comfort and analgesia as patients' needs differ.
Patient-controlled sedation (PCS) is a valid option, initially adapted from post surgery patient-controlled analgesia. It allows patients to titrate sedative medication to their comfort and therefore present an option that addresses the needs of patients with strong desire to maintain sense of control during procedures.
This study was designed to compare total propofol requirement between PCS versus TCI sedation (TCIS), complications and patient satisfaction, in patients undergoing lower limb orthopaedic surgery under CNB.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Kuala Lumpur
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Cheras、Kuala Lumpur、马来西亚、56000
- Pusat Perubatan Universiti Kebangsaan Malaysia
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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:
- American Society of Anesthesiologists (ASA) I or II.
- Aged 18-65 years.
- Elective lower limb orthopaedic surgery under CNB anticipated to last for 1.5 to 2 hours
Exclusion Criteria:
- Body Mass Index (BMI) > 30kg/m2
- Unable to cooperate (eg. mental disorders, language barrier)
- Drug abuse
- Alcoholism (chronic daily alcohol intake greater than 75 g of pure alcohol for ≥ 2 years, where 75g of alcohol = 5 cans of beer, 1 bottle of wine or half a pint of distilled spirit)
- Contraindications to the study drugs
- Pregnancy
- Significant pulmonary or cardiovascular diseases, including obstructive sleep apnoea and obesity hypoventilation syndrome
- Features of difficult airway
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Group PCS
Patients in Group PCS (patient-controlled sedation) received intravenous (IV) propofol via a patient controlled analgesia (PCA) infusion pump.
The machine was set to deliver a demand bolus dose of 0.25 mg/kg with 1-minute lockout interval, without basal infusion.The patient was instructed to press on a hand-held device as often as required, to achieve their desired level of comfort or sedation.
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Patient-controlled propofol boluses for patients undergoing elective orthopaedic surgery under central neuraxial block
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有源比较器：Group TCIS
Patients in Group TCIS (target-controlled infusion sedation) received IV propofol via a target-controlled infusion (TCI) pump, targeted at an initial effect site concentration (Cet) of 0.6 μg/ml, using the Schnider pharmacokinetic model.
Upon attainment of 0.6 μg/ml Cet, the patient's sedation level was assessed.
The Cet was increased or reduced accordingly by 0.2 μg/ml to attain an OAA/S score of 3.
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Patient-controlled propofol boluses for patients undergoing elective orthopaedic surgery under central neuraxial block
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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total propofol requirement between PCS versus TCI sedation (TCIS)
大体时间：Assessed from the beginning to the end of sedation, at the average of 120 minutes
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Total propofol requirement in both groups was calculated in mg/kg/hour.
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Assessed from the beginning to the end of sedation, at the average of 120 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient satisfaction assessed by a 10-point numerical scale
大体时间：Within one hour after recovery from sedation
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Assessed using a 10-point verbal numerical rating scale (1 to 10), where 1 was regarded as extremely dissatisfied and 10 extremely satisfied.
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Within one hour after recovery from sedation
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Complications including incidence of hypotension, bradycardia, hypopnea, oxygen desaturation and over sedation
大体时间：Assessed from the beginning to the end of sedation, at the average of 120 minutes
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Documented as Yes or No for each specified complication
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Assessed from the beginning to the end of sedation, at the average of 120 minutes
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合作者和调查者
调查人员
- 首席研究员：Nadia Md Nor, MMED(Anaes)、Universiti Kebangsaan Malaysia Medical Centre
出版物和有用的链接
一般刊物
- Wahlen BM, Kilian M, Schuster F, Muellenbach R, Roewer N, Kranke P. Patient-controlled versus continuous anesthesiologist-controlled sedation using propofol during regional anesthesia in orthopedic procedures--a pilot study. Expert Opin Pharmacother. 2008 Nov;9(16):2733-9. doi: 10.1517/14656566.9.16.2733.
- Ekin A, Donmez F, Taspinar V, Dikmen B. Patient-controlled sedation in orthopedic surgery under regional anesthesia: a new approach in procedural sedation. Braz J Anesthesiol. 2013 Sep-Oct;63(5):410-4. doi: 10.1016/j.bjan.2012.07.012.
- Singh T, Ravishankar M. Conscious sedation with propofol for surgeries under spinal anaesthesia: anaesthesiologist versus patient controlled. J Anaesthesiol Clin Pharmacol. 21:169-173, 2005.
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- FF-2017-265
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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