SPI-guided Analgesia During CEA Under RA
- Conditions
- Carotid Artery Stenoses
- Interventions
- Drug: infiltration rescue intraoperative analgesiaDrug: rescue IADrug: rescue antyhypertensive medicationDrug: rescue antyemetic medicationDrug: rescue antyhypotensive medication
- Registration Number
- NCT04500249
- Lead Sponsor
- Medical University of Silesia
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 105
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CPB infiltration rescue intraoperative analgesia cervical plexus block was performed with 0,5% bupivacaine using Moore's technique CPB rescue antyhypotensive medication cervical plexus block was performed with 0,5% bupivacaine using Moore's technique CPB with SPI guided analgesia infiltration rescue intraoperative 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 CPB rescue IA cervical plexus block was performed with 0,5% bupivacaine using Moore's technique CPB with SPI guided analgesia rescue IA 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 CPB plus SPI guided analgesia plus carotid artery block rescue antyhypotensive medication 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 CPB rescue antyhypertensive medication cervical plexus block was performed with 0,5% bupivacaine using Moore's technique CPB rescue antyemetic medication cervical plexus block was performed with 0,5% bupivacaine using Moore's technique CPB plus SPI guided analgesia plus carotid artery block rescue antyhypertensive medication 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 CPB with SPI guided analgesia rescue antyhypotensive medication 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 CPB plus SPI guided analgesia plus carotid artery block rescue antyemetic medication 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 CPB with SPI guided analgesia rescue antyhypertensive medication 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 CPB with SPI guided analgesia rescue antyemetic medication 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 CPB plus SPI guided analgesia plus carotid artery block infiltration rescue intraoperative analgesia 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 CPB plus SPI guided analgesia plus carotid artery block rescue IA 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
- Primary Outcome Measures
Name Time Method haemodynamic stability intraoperatively variations of haemodynamic parametres will be analysed
- Secondary Outcome Measures
Name Time Method pain perception using SPI value variations intraoperatively pain perception using SPI value variations will be analysed
Trial Locations
- Locations (1)
Medical University of Silesia
🇵🇱Sosnowiec, Silesia, Poland