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| Name | Class |
|---|---|
| Silesian University of Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPB | Experimental | cervical plexus block was performed with 0,5% bupivacaine using Moore's technique |
|
| CPB with SPI guided analgesia | Experimental | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| infiltration rescue intraoperative analgesia | Drug | in the case of intraoperative pain perception, rescue infiltration analgesia using 1 % lidocaine administered by the operator into the operation field. |
| Measure | Description | Time Frame |
|---|---|---|
| haemodynamic stability | variations of haemodynamic parametres will be analysed | intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| pain perception using SPI value variations | pain perception using SPI value variations will be analysed | intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| ischaemic stroke | presence of ischaemic stroke will be observed | from beginning of operation till discharge from hospital |
| dysarthria | presence of dysarthria will be observed |
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michał J Stasiowski, M.D | Contact | 696797922 | 0048 | mstasiowski.anest@gmail.com |
| Lech Krawczyk, Ph. Dr | Contact | 32-3682341 | 0048 | lech.kraw@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Michał J Stasiowski, M.D | Medical University of Silesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Silesia | Recruiting | Sosnowiec | Silesian Voivodeship | 41-200 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25032676 | Result | Gruenewald M, Herz J, Schoenherr T, Thee C, Steinfath M, Bein B. Measurement of the nociceptive balance by Analgesia Nociception Index and Surgical Pleth Index during sevoflurane-remifentanil anesthesia. Minerva Anestesiol. 2015 May;81(5):480-9. Epub 2014 Jul 17. | |
| 23471754 | Result | Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6. |
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publication in AiIT
within a year
on a reasonable request
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| C538013 | Early-onset ataxia with oculomotor apraxia and hypoalbuminemia |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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neither participant nor operator is aware of rescue analgesia protocol
|
| rescue IA | Drug | in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist |
|
| rescue antyhypertensive medication | Drug | in the case of intraoperative hypertension reluctant to rescue analgesia, rescue intravenous antihypertensive medication using 10 mcg of urapidil will be administered by anaesthesiologist |
|
| rescue antyemetic medication | Drug | in the case of postoperative nausea and vomitting, rescue intravenous antiemetic medication using 4 mg of ondansetron will be administered by anaesthesiologist |
|
| rescue antyhypotensive medication | Drug | in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist |
|
| rescue antyhypotensive medication | Drug | in the case of intraoperative bradycardia, rescue intravenous antihypotensive medication using 500 mcg of atropine will be administered by anaesthesiologist |
|
| from beginning of operation till discharge from hospital, approximately 2 - 14 days |
| limb paresis | presence of limb paresis will be observed | from beginning of operation till discharge from hospital, approximately 2 - 14 days |
| hoarseness | presence of hoarseness will be observed | from beginning of operation till discharge from hospital, approximately 2 - 14 days |
| face semiparesis | presence of semiparesis will be observed | from beginning of operation till discharge from hospital, approximately 2 - 14 days |
| postoperative nausea and vomitting | presence of postoperative nausea and vomitting will be observed | from beginning of operation till discharge from hospital, approximately 2 - 14 days |
| 24012235 | Result | Gruenewald M, Ilies C. Monitoring the nociception-anti-nociception balance. Best Pract Res Clin Anaesthesiol. 2013 Jun;27(2):235-47. doi: 10.1016/j.bpa.2013.06.007. |
| 24535604 | Result | Gruenewald M, Willms S, Broch O, Kott M, Steinfath M, Bein B. Sufentanil administration guided by surgical pleth index vs standard practice during sevoflurane anaesthesia: a randomized controlled pilot study. Br J Anaesth. 2014 May;112(5):898-905. doi: 10.1093/bja/aet485. Epub 2014 Feb 16. |
| 27583920 | Result | Won YJ, Lim BG, Lee SH, Park S, Kim H, Lee IO, Kong MH. Comparison of relative oxycodone consumption in surgical pleth index-guided analgesia versus conventional analgesia during sevoflurane anesthesia: A randomized controlled trial. Medicine (Baltimore). 2016 Aug;95(35):e4743. doi: 10.1097/MD.0000000000004743. |
| 25440694 | Result | Calderon AL, Zetlaoui P, Benatir F, Davidson J, Desebbe O, Rahali N, Truc C, Feugier P, Lermusiaux P, Allaouchiche B, Boselli E. Ultrasound-guided intermediate cervical plexus block for carotid endarterectomy using a new anterior approach: a two-centre prospective observational study. Anaesthesia. 2015 Apr;70(4):445-51. doi: 10.1111/anae.12960. Epub 2014 Dec 1. |
| 30656404 | Result | Tsujikawa S, Ikeshita K. Low-dose dexmedetomidine provides hemodynamics stabilization during emergence and recovery from general anesthesia in patients undergoing carotid endarterectomy: a randomized double-blind, placebo-controlled trial. J Anesth. 2019 Apr;33(2):266-272. doi: 10.1007/s00540-019-02612-w. Epub 2019 Jan 17. |
| 28913451 | Result | Zdrehus C. Anaesthesia for carotid endarterectomy - general or loco-regional? Rom J Anaesth Intensive Care. 2015 Apr;22(1):17-24. |
| 26458845 | Result | Ishiguro T, Yoneyama T, Ishikawa T, Yamaguchi K, Kawashima A, Kawamata T, Okada Y. Perioperative and Long-term Outcomes of Carotid Endarterectomy for Japanese Asymptomatic Cervical Carotid Artery Stenosis: A Single Institution Study. Neurol Med Chir (Tokyo). 2015;55(11):830-7. doi: 10.2176/nmc.oa.2014-0398. Epub 2015 Oct 9. |
| 28018501 | Result | Lee J, Huh U, Song S, Chung SW, Sung SM, Cho HJ. Regional Anesthesia with Dexmedetomidine Infusion: A Feasible Method for the Awake Test during Carotid Endarterectomy. Ann Vasc Dis. 2016;9(4):295-299. doi: 10.3400/avd.oa.16-00049. Epub 2016 Oct 11. |
| 29624030 | Result | Scimia P, Giordano C, Basso Ricci E, Petrucci E, Fusco P. The ultrasound-guided C2-C4 compartment block combined to dexmedetomidine sedation: an ideal approach for carotid endarterectomy in awake patients. Minerva Anestesiol. 2018 Oct;84(10):1226-1227. doi: 10.23736/S0375-9393.18.12780-5. Epub 2018 Apr 5. No abstract available. |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |