SPI-guided Analgesia in Patients Undergoing Carotid Endarterectomy Under Cervical Plexus Block
试验速览
- 阶段
- 不适用
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- haemodynamic stability
研究概览
简要总结
The aim of this randomized prospective trial is to assess the utility of Adequacy of Anaesthesia technique (Response Entropy and Surgical Pleth Index) for monitoring pain perception intraoperatively, maintainance of hemodynamic stability during anesthesia and its influence on postoperative outcomes, in patients undergoing carotid endarterectomy under cervical plexus block.
详细描述
Carotid artery stenosis constitutes a major risk factor for ischemic stroke so carotid endarterectomy is performed to protects patients with severe atherosclerotic carotid artery stenosis against stroke.
Surgical Pleth Index (SPI) is reported to properly reflect nociception-antinociception balance in patients undergoing surgical procedures, where a value of 100 corresponds to a high stress level and a value of 0 to a low stress level; values near 50 or increase in value > delta 10 correspond to the stress level which is known to reflect requirement for rescue analgesia.
A randomized interventional trial to evaluate the effects of SPI-guided rescue analgesia on hemodynamic stability during anesthesia in patients undergoing carotid endarterectomy under cervical plexus block.
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
- Single (Participant)
盲法说明
neither participant nor operator is aware of rescue analgesia protocol
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of stenosis of carotid artery written consent to participate in the study written consent to undergo carotid endarterectomy under regional anaesthesia of cervical plexus using Moore's technique general heath condition I-III of American Society of Anaesthesiology
排除标准
- •necessity of administration of vasoactive drugs influencing SPI monitoring pregnancy
- •anatomical malformation that make monitoring using SE sensor impossible
- •general atherosclerosis and heart rhythm disturbances impairing SPI monitoring
- •chronic medication using opioid drugs leading to resistancy to opioids.
- •farmacotherapy with anticoagulants
- •allergy to local anaesthetics
研究组 & 干预措施
CPB
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique
干预措施: rescue antyhypotensive medication (Drug)
CPB
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique
干预措施: infiltration rescue intraoperative analgesia (Drug)
CPB
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique
干预措施: rescue IA (Drug)
CPB
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique
干预措施: rescue antyhypertensive medication (Drug)
CPB
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique
干预措施: rescue antyemetic medication (Drug)
CPB with SPI guided analgesia
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique alongside with SPI-guided rescue analgesia using 1% lidokaine and intravenous fentanyl
干预措施: infiltration rescue intraoperative analgesia (Drug)
CPB with SPI guided analgesia
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique alongside with SPI-guided rescue analgesia using 1% lidokaine and intravenous fentanyl
干预措施: rescue IA (Drug)
CPB with SPI guided analgesia
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique alongside with SPI-guided rescue analgesia using 1% lidokaine and intravenous fentanyl
干预措施: rescue antyhypertensive medication (Drug)
CPB with SPI guided analgesia
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique alongside with SPI-guided rescue analgesia using 1% lidokaine and intravenous fentanyl
干预措施: rescue antyemetic medication (Drug)
CPB with SPI guided analgesia
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique alongside with SPI-guided rescue analgesia using 1% lidokaine and intravenous fentanyl
干预措施: rescue antyhypotensive medication (Drug)
CPB plus SPI guided analgesia plus carotid artery block
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique combined ith US-guided carotid artery block alongside with SPI-guided rescue analgesia using 1% lidokaine and intravenous fentanyl
干预措施: infiltration rescue intraoperative analgesia (Drug)
CPB plus SPI guided analgesia plus carotid artery block
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique combined ith US-guided carotid artery block alongside with SPI-guided rescue analgesia using 1% lidokaine and intravenous fentanyl
干预措施: rescue IA (Drug)
CPB plus SPI guided analgesia plus carotid artery block
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique combined ith US-guided carotid artery block alongside with SPI-guided rescue analgesia using 1% lidokaine and intravenous fentanyl
干预措施: rescue antyhypertensive medication (Drug)
CPB plus SPI guided analgesia plus carotid artery block
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique combined ith US-guided carotid artery block alongside with SPI-guided rescue analgesia using 1% lidokaine and intravenous fentanyl
干预措施: rescue antyemetic medication (Drug)
CPB plus SPI guided analgesia plus carotid artery block
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique combined ith US-guided carotid artery block alongside with SPI-guided rescue analgesia using 1% lidokaine and intravenous fentanyl
干预措施: rescue antyhypotensive medication (Drug)
结局指标
主要结局
haemodynamic stability
时间窗: intraoperatively
variations of haemodynamic parametres will be analysed
次要结局
- pain perception using SPI value variations(intraoperatively)
研究者
Michał Stasiowski
Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy
Medical University of Silesia