Carotid Artery Stenoses
Conditions
Keywords
Surgical Pleth Index (SPI), Cervical plexus block, Adequacy of Anaesthesia (AoA, State Entropy, Stroke
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.
Interventions
DRUGinfiltration rescue intraoperative analgesia
in the case of intraoperative pain perception, rescue infiltration analgesia using 1 % lidocaine administered by the operator into the operation field.
DRUGrescue IA
in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist
DRUGrescue antyhypertensive medication
in the case of intraoperative hypertension reluctant to rescue analgesia, rescue intravenous antihypertensive medication using 10 mcg of urapidil will be administered by anaesthesiologist
DRUGrescue antyemetic medication
in the case of postoperative nausea and vomitting, rescue intravenous antiemetic medication using 4 mg of ondansetron will be administered by anaesthesiologist
DRUGrescue antyhypotensive medication
in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist
Sponsors
Silesian University of Medicine
Medical University of Silesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
neither participant nor operator is aware of rescue analgesia protocol
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| haemodynamic stability | intraoperatively | variations of haemodynamic parametres will be analysed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain perception using SPI value variations | intraoperatively | pain perception using SPI value variations will be analysed |
Other
| Measure | Time frame | Description |
|---|---|---|
| dysarthria | from beginning of operation till discharge from hospital, approximately 2 - 14 days | presence of dysarthria will be observed |
| limb paresis | from beginning of operation till discharge from hospital, approximately 2 - 14 days | presence of limb paresis will be observed |
| hoarseness | from beginning of operation till discharge from hospital, approximately 2 - 14 days | presence of hoarseness will be observed |
| face semiparesis | from beginning of operation till discharge from hospital, approximately 2 - 14 days | presence of semiparesis will be observed |
| postoperative nausea and vomitting | from beginning of operation till discharge from hospital, approximately 2 - 14 days | presence of postoperative nausea and vomitting will be observed |
| ischaemic stroke | from beginning of operation till discharge from hospital | presence of ischaemic stroke will be observed |
Countries
Poland
Contacts
Primary ContactMichał J Stasiowski, M.D
Backup ContactLech Krawczyk, Ph. Dr
Outcome results
None listed