SPI-guided Analgesia in Patients Undergoing Carotid Endarterectomy Under Cervical Plexus Block
Overview
- Phase
- Not Applicable
- Intervention
- rescue antyhypotensive medication
- Conditions
- Carotid Artery Stenoses
- Sponsor
- Medical University of Silesia
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- haemodynamic stability
- Last Updated
- 5 years ago
Overview
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.
Investigators
Michał Stasiowski
Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy
Medical University of Silesia
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
CPB
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique
Intervention: rescue antyhypotensive medication
CPB
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique
Intervention: infiltration rescue intraoperative analgesia
CPB
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique
Intervention: rescue IA
CPB
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique
Intervention: rescue antyhypertensive medication
CPB
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique
Intervention: rescue antyemetic medication
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
Intervention: infiltration rescue intraoperative analgesia
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
Intervention: rescue IA
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
Intervention: rescue antyhypertensive medication
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
Intervention: rescue antyemetic medication
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
Intervention: rescue antyhypotensive medication
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
Intervention: infiltration rescue intraoperative analgesia
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
Intervention: rescue IA
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
Intervention: rescue antyhypertensive medication
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
Intervention: rescue antyemetic medication
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
Intervention: rescue antyhypotensive medication
Outcomes
Primary Outcomes
haemodynamic stability
Time Frame: intraoperatively
variations of haemodynamic parametres will be analysed
Secondary Outcomes
- pain perception using SPI value variations(intraoperatively)