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- Ensaio Clínico NCT04500249
SPI-guided Analgesia During CEA Under RA (CEA)
SPI-guided Analgesia in Patients Undergoing Carotid Endarterectomy Under Cervical Plexus Block
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Michał J Stasiowski, M.D
- Número de telefone: 0048 696797922
- E-mail: mstasiowski.anest@gmail.com
Estude backup de contato
- Nome: Lech Krawczyk, Ph. Dr
- Número de telefone: 0048 32-3682341
- E-mail: lech.kraw@gmail.com
Locais de estudo
-
-
Silesia
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Sosnowiec, Silesia, Polônia, 41-200
- Recrutamento
- Medical University of Silesia
-
Contato:
- Michał J. Stasiowski
- Número de telefone: 0048 696797922
- E-mail: mstasiowski.anest@gmail.com
-
Contato:
- Lech Krawczyk, Ph. Dr.
- Número de telefone: 0048 323682341
- E-mail: lech.kraw@gmail.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: CPB
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique
|
in the case of intraoperative pain perception, rescue infiltration analgesia using 1 % lidocaine administered by the operator into the operation field.
Outros nomes:
in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist
in the case of intraoperative hypertension reluctant to rescue analgesia, rescue intravenous antihypertensive medication using 10 mcg of urapidil will be administered by anaesthesiologist
in the case of postoperative nausea and vomitting, rescue intravenous antiemetic medication using 4 mg of ondansetron will be administered by anaesthesiologist
in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist
in the case of intraoperative bradycardia, rescue intravenous antihypotensive medication using 500 mcg of atropine will be administered by anaesthesiologist
|
Experimental: 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
|
in the case of intraoperative pain perception, rescue infiltration analgesia using 1 % lidocaine administered by the operator into the operation field.
Outros nomes:
in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist
in the case of intraoperative hypertension reluctant to rescue analgesia, rescue intravenous antihypertensive medication using 10 mcg of urapidil will be administered by anaesthesiologist
in the case of postoperative nausea and vomitting, rescue intravenous antiemetic medication using 4 mg of ondansetron will be administered by anaesthesiologist
in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist
in the case of intraoperative bradycardia, rescue intravenous antihypotensive medication using 500 mcg of atropine will be administered by anaesthesiologist
|
Experimental: 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
|
in the case of intraoperative pain perception, rescue infiltration analgesia using 1 % lidocaine administered by the operator into the operation field.
Outros nomes:
in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist
in the case of intraoperative hypertension reluctant to rescue analgesia, rescue intravenous antihypertensive medication using 10 mcg of urapidil will be administered by anaesthesiologist
in the case of postoperative nausea and vomitting, rescue intravenous antiemetic medication using 4 mg of ondansetron will be administered by anaesthesiologist
in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist
in the case of intraoperative bradycardia, rescue intravenous antihypotensive medication using 500 mcg of atropine will be administered by anaesthesiologist
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
haemodynamic stability
Prazo: intraoperatively
|
variations of haemodynamic parametres will be analysed
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intraoperatively
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
pain perception using SPI value variations
Prazo: intraoperatively
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pain perception using SPI value variations will be analysed
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intraoperatively
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
ischaemic stroke
Prazo: from beginning of operation till discharge from hospital
|
presence of ischaemic stroke will be observed
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from beginning of operation till discharge from hospital
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dysarthria
Prazo: from beginning of operation till discharge from hospital, approximately 2 - 14 days
|
presence of dysarthria will be observed
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from beginning of operation till discharge from hospital, approximately 2 - 14 days
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limb paresis
Prazo: from beginning of operation till discharge from hospital, approximately 2 - 14 days
|
presence of limb paresis will be observed
|
from beginning of operation till discharge from hospital, approximately 2 - 14 days
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hoarseness
Prazo: from beginning of operation till discharge from hospital, approximately 2 - 14 days
|
presence of hoarseness will be observed
|
from beginning of operation till discharge from hospital, approximately 2 - 14 days
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face semiparesis
Prazo: from beginning of operation till discharge from hospital, approximately 2 - 14 days
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presence of semiparesis will be observed
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from beginning of operation till discharge from hospital, approximately 2 - 14 days
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postoperative nausea and vomitting
Prazo: from beginning of operation till discharge from hospital, approximately 2 - 14 days
|
presence of postoperative nausea and vomitting will be observed
|
from beginning of operation till discharge from hospital, approximately 2 - 14 days
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Zdrehus C. Anaesthesia for carotid endarterectomy - general or loco-regional? Rom J Anaesth Intensive Care. 2015 Apr;22(1):17-24.
- 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.
- 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.
- 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.
Datas de registro do estudo
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Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
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Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SilesianMUKOAiIT4
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- Termo de Consentimento Livre e Esclarecido (TCLE)
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