Carotid Artery StenosesCEANCT04500249
SPI-guided Analgesia During CEA Under RA
A study testing infiltration rescue intraoperative analgesia, rescue IA and rescue antyhypertensive medication in people with Carotid Artery Stenoses, run by Medical University of Silesia at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carotid Artery Stenoses
- What is being tested?
- infiltration rescue intraoperative analgesia, rescue IA and rescue antyhypertensive medication
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2015to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Silesia
Sosnowiec, Silesian Voivodeship, 41-200
Michał J. Stasiowski, 696797922 ext. 0048, mstasiowski.anest@gmail.com
Lech Krawczyk, Ph. Dr., 323682341 ext. 0048, lech.kraw@gmail.com
About this study
Official title: SPI-guided Analgesia in Patients Undergoing Carotid Endarterectomy Under Cervical Plexus Block
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.
Read the 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.
- Conditions
- Carotid Artery Stenoses
- Being tested
- infiltration rescue intraoperative analgesia, rescue IA, rescue antyhypertensive medication, rescue antyemetic medication, rescue antyhypotensive medication
- Keywords
- Surgical Pleth Index (SPI), Cervical plexus block, Adequacy of Anaesthesia (AoA, State Entropy, Stroke
- Medical subject headings
- Carotid Stenosis, Early-onset ataxia with oculomotor apraxia and hypoalbuminemia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infiltration rescue intraoperative analgesiaDrug
Also called rescue LA
in the case of intraoperative pain perception, rescue infiltration analgesia using 1 % lidocaine administered by the operator into the operation field.
rescue IADrug
in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist
rescue antyhypertensive medicationDrug
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 medicationDrug
in the case of postoperative nausea and vomitting, rescue intravenous antiemetic medication using 4 mg of ondansetron will be administered by anaesthesiologist
rescue antyhypotensive medicationDrug
in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist
rescue antyhypotensive medicationDrug
in the case of intraoperative bradycardia, rescue intravenous antihypotensive medication using 500 mcg of atropine will be administered by anaesthesiologist
| Study group | Role | What they receive |
|---|---|---|
| CPB | Experimental | cervical plexus block was performed with 0,5% bupivacaine using Moore's technique Receives: Drug: infiltration rescue intraoperative analgesia; Drug: rescue IA; Drug: rescue antyhypertensive medication; Drug: rescue antyemetic medication; Drug: rescue antyhypotensive medication |
| 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 Receives: Drug: infiltration rescue intraoperative analgesia; Drug: rescue IA; Drug: rescue antyhypertensive medication; Drug: rescue antyemetic medication; Drug: rescue antyhypotensive medication |
| 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 Receives: Drug: infiltration rescue intraoperative analgesia; Drug: rescue IA; Drug: rescue antyhypertensive medication; Drug: rescue antyemetic medication; Drug: rescue antyhypotensive medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
haemodynamic stability
variations of haemodynamic parametres will be analysed
Measured: intraoperatively
Secondary outcomes (1)
pain perception using SPI value variations
pain perception using SPI value variations will be analysed
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Oct 2015
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery StenosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Collaborators
- Silesian University of Medicine
- Responsible party
- Principal investigator, Michał Stasiowski, Medical University of Silesia
- Investigators
- Michał J Stasiowski, M.D, Principal investigator, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500249
- Sponsor's protocol ID
- SilesianMUKOAiIT4
- Acronym
- CEA
- Status last verified
- Jul 2020
- First submitted
- 14 Apr 2019
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: publication in AiIT
Publications
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.
PubMed 25032676Gruenewald 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.
PubMed 23471754Gruenewald 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.
PubMed 24012235Gruenewald 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.
PubMed 24535604Won 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.
PubMed 27583920Calderon 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.
PubMed 25440694Tsujikawa 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.
PubMed 30656404Zdrehus C. Anaesthesia for carotid endarterectomy - general or loco-regional? Rom J Anaesth Intensive Care. 2015 Apr;22(1):17-24.
PubMed 28913451Ishiguro 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.
PubMed 26458845Lee 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.
PubMed 28018501Scimia 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.
PubMed 29624030
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPI-guided Analgesia in Patients Undergoing Carotid Endarterectomy Under Cervical Plexus Block
- ClinicalTrials.gov ID
- NCT04500249
- Acronym / sponsor ID
- CEA / SilesianMUKOAiIT4
- Conditions
- Carotid Artery Stenoses
- Keywords
- Surgical Pleth Index (SPI), Cervical plexus block, Adequacy of Anaesthesia (AoA, State Entropy, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Collaborators
- Silesian University of Medicine
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPB | Experimental | Drug: infiltration rescue intraoperative analgesia, Drug: rescue IA, Drug: rescue antyhypertensive medication, Drug: rescue antyemetic medication, Drug: rescue antyhypotensive medicationcervical plexus block was performed with 0,5% bupivacaine using Moore's technique |
| CPB with SPI guided analgesia | Experimental | Drug: infiltration rescue intraoperative analgesia, Drug: rescue IA, Drug: rescue antyhypertensive medication, Drug: rescue antyemetic medication, Drug: rescue antyhypotensive medicationcervical 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 | Drug: infiltration rescue intraoperative analgesia, Drug: rescue IA, Drug: rescue antyhypertensive medication, Drug: rescue antyemetic medication, Drug: rescue antyhypotensive medicationcervical 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infiltration rescue intraoperative analgesiaAlso: rescue LAin the case of intraoperative pain perception, rescue infiltration analgesia using 1 % lidocaine administered by the operator into the operation field. | Drug | CPB, CPB plus SPI guided analgesia plus carotid artery block, CPB with SPI guided analgesia |
| rescue IAin the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist | Drug | CPB, CPB plus SPI guided analgesia plus carotid artery block, CPB with SPI guided analgesia |
| rescue antyhypertensive medicationin the case of intraoperative hypertension reluctant to rescue analgesia, rescue intravenous antihypertensive medication using 10 mcg of urapidil will be administered by anaesthesiologist | Drug | CPB, CPB plus SPI guided analgesia plus carotid artery block, CPB with SPI guided analgesia |
| rescue antyemetic medicationin the case of postoperative nausea and vomitting, rescue intravenous antiemetic medication using 4 mg of ondansetron will be administered by anaesthesiologist | Drug | CPB, CPB plus SPI guided analgesia plus carotid artery block, CPB with SPI guided analgesia |
| rescue antyhypotensive medicationin the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist | Drug | CPB, CPB plus SPI guided analgesia plus carotid artery block, CPB with SPI guided analgesia |
| rescue antyhypotensive medicationin the case of intraoperative bradycardia, rescue intravenous antihypotensive medication using 500 mcg of atropine will be administered by anaesthesiologist | Drug | CPB, CPB plus SPI guided analgesia plus carotid artery block, CPB with SPI guided analgesia |
Primary outcome
haemodynamic stability
Time frame: intraoperatively
variations of haemodynamic parametres will be analysed
1 secondary outcome
pain perception using SPI value variations
Time frame: intraoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Results publication: PubMed 25032676Gruenewald 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.
- Results publication: PubMed 23471754Gruenewald 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.
- Results publication: PubMed 24012235Gruenewald 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.
- Results publication: PubMed 24535604Gruenewald 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.
- Results publication: PubMed 27583920Won 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.
- Results publication: PubMed 25440694Calderon 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.
- Results publication: PubMed 30656404Tsujikawa 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.
- Results publication: PubMed 28913451Zdrehus C. Anaesthesia for carotid endarterectomy - general or loco-regional? Rom J Anaesth Intensive Care. 2015 Apr;22(1):17-24.
- Results publication: PubMed 26458845Ishiguro 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.
- Results publication: PubMed 28018501Lee 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.
- Results publication: PubMed 29624030Scimia 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.
- Individual participant dataSharing planned: Yes. publication in AiIT
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michał J Stasiowski, M.D principal investigator
Medical University of Silesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infiltration rescue intraoperative analgesia, rescue IA and rescue antyhypertensive medication in people with Carotid Artery Stenoses, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michał J Stasiowski, M.D (696797922 ext. 0048, mstasiowski.anest@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
haemodynamic stability (time frame: intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04500249, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.