SPI-guided Analgesia During CEA Under RA

Study Overview
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Brief Summary
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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
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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.

Official Title
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SPI-guided Analgesia in Patients Undergoing Carotid Endarterectomy Under Cervical Plexus Block

Conditions
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Carotid Artery Stenoses

Intervention / Treatment
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* Drug: infiltration rescue intraoperative analgesia
* Drug: rescue IA
* Drug: rescue antyhypertensive medication
* Drug: rescue antyemetic medication
* Drug: rescue antyhypotensive medication
* Drug: rescue antyhypotensive medication


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPB<br>cervical plexus block was performed with 0,5% bupivacaine using Moore's technique | Drug: infiltration rescue intraoperative analgesia<br>* in the case of intraoperative pain perception, rescue infiltration analgesia using 1 % lidocaine administered by the operator into the operation field.<br>* Other names: rescue LA;Drug: rescue IA<br>* in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist<br>Drug: rescue antyhypertensive medication<br>* in the case of intraoperative hypertension reluctant to rescue analgesia, rescue intravenous antihypertensive medication using 10 mcg of urapidil will be administered by anaesthesiologist<br>Drug: rescue antyemetic medication<br>* in the case of postoperative nausea and vomitting, rescue intravenous antiemetic medication using 4 mg of ondansetron will be administered by anaesthesiologist<br>Drug: rescue antyhypotensive medication<br>* in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist<br>Drug: rescue antyhypotensive medication<br>* in the case of intraoperative bradycardia, rescue intravenous antihypotensive medication using 500 mcg of atropine will be administered by anaesthesiologist<br>|
| Experimental: CPB with SPI guided analgesia<br>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 | Drug: infiltration rescue intraoperative analgesia<br>* in the case of intraoperative pain perception, rescue infiltration analgesia using 1 % lidocaine administered by the operator into the operation field.<br>* Other names: rescue LA;Drug: rescue IA<br>* in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist<br>Drug: rescue antyhypertensive medication<br>* in the case of intraoperative hypertension reluctant to rescue analgesia, rescue intravenous antihypertensive medication using 10 mcg of urapidil will be administered by anaesthesiologist<br>Drug: rescue antyemetic medication<br>* in the case of postoperative nausea and vomitting, rescue intravenous antiemetic medication using 4 mg of ondansetron will be administered by anaesthesiologist<br>Drug: rescue antyhypotensive medication<br>* in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist<br>Drug: rescue antyhypotensive medication<br>* in the case of intraoperative bradycardia, rescue intravenous antihypotensive medication using 500 mcg of atropine will be administered by anaesthesiologist<br>|
| Experimental: CPB plus SPI guided analgesia plus carotid artery block<br>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 | Drug: infiltration rescue intraoperative analgesia<br>* in the case of intraoperative pain perception, rescue infiltration analgesia using 1 % lidocaine administered by the operator into the operation field.<br>* Other names: rescue LA;Drug: rescue IA<br>* in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist<br>Drug: rescue antyhypertensive medication<br>* in the case of intraoperative hypertension reluctant to rescue analgesia, rescue intravenous antihypertensive medication using 10 mcg of urapidil will be administered by anaesthesiologist<br>Drug: rescue antyemetic medication<br>* in the case of postoperative nausea and vomitting, rescue intravenous antiemetic medication using 4 mg of ondansetron will be administered by anaesthesiologist<br>Drug: rescue antyhypotensive medication<br>* in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist<br>Drug: rescue antyhypotensive medication<br>* in the case of intraoperative bradycardia, rescue intravenous antihypotensive medication using 500 mcg of atropine will be administered by anaesthesiologist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| haemodynamic stability | variations of haemodynamic parametres will be analysed | intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain perception using SPI value variations | pain perception using SPI value variations will be analysed | intraoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical Pleth Index (SPI), State Entropy, Cervical plexus block, Adequacy of Anaesthesia (AoA, Stroke