SPI-guided Analgesia During CEA Under RA

NCT04500249 | Unknown DMC

• 1 other identifier: SilesianMUKOAiIT4
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Stenoses

Keywords

Surgical Pleth Index (SPI); Cervical plexus block; Adequacy of Anaesthesia (AoA; State Entropy; Stroke

Outcome Measures

Primary Outcomes (1)

• haemodynamic stability

  variations of haemodynamic parametres will be analysed

  intraoperatively

Secondary Outcomes (1)

• pain perception using SPI value variations

  intraoperatively

Other Outcomes (6)

• ischaemic stroke

  from beginning of operation till discharge from hospital

• dysarthria

  from beginning of operation till discharge from hospital, approximately 2 - 14 days

• limb paresis

  from beginning of operation till discharge from hospital, approximately 2 - 14 days

Study Arms (3)

CPB

EXPERIMENTAL

cervical plexus block was performed with 0,5% bupivacaine using Moore's technique

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

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

Drug: infiltration rescue intraoperative analgesia; Drug: rescue IA; Drug: rescue antyhypertensive medication; Drug: rescue antyemetic medication; Drug: rescue antyhypotensive medication

Interventions

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.

Also known as: rescue LA

CPB; CPB plus SPI guided analgesia plus carotid artery block; CPB with SPI guided analgesia

rescue IA DRUG

in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist

CPB; CPB plus SPI guided analgesia plus carotid artery block; CPB with SPI guided analgesia

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

CPB; CPB plus SPI guided analgesia plus carotid artery block; CPB with SPI guided analgesia

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

CPB; CPB plus SPI guided analgesia plus carotid artery block; CPB with SPI guided analgesia

rescue antyhypotensive medication DRUG

in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist

CPB; CPB plus SPI guided analgesia plus carotid artery block; CPB with SPI guided analgesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Silesia: lead
• Silesian University of Medicine: collaborator

Study Sites (1)

Medical University of Silesia

Sosnowiec, Silesian Voivodeship, 41-200, Poland

RECRUITING

Related Publications (11)

• 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.

  PMID: 25032676 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.

  PMID: 23471754 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.

  PMID: 24012235 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.

  PMID: 24535604 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.

  PMID: 27583920 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.

  PMID: 25440694 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.

  PMID: 30656404 RESULT

• Zdrehus C. Anaesthesia for carotid endarterectomy - general or loco-regional? Rom J Anaesth Intensive Care. 2015 Apr;22(1):17-24.

  PMID: 28913451 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.

  PMID: 26458845 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.

  PMID: 28018501 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.

  PMID: 29624030 RESULT

MeSH Terms

Conditions

Carotid Stenosis; Early-onset ataxia with oculomotor apraxia and hypoalbuminemia; Stroke

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michał J Stasiowski, M.D

  Medical University of Silesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michał J Stasiowski, M.D

CONTACT

696797922; mstasiowski.anest@gmail.com

Lech Krawczyk, Ph. Dr

CONTACT

32-3682341; lech.kraw@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: neither participant nor operator is aware of rescue analgesia protocol
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy

Study Record Dates

• First Submitted: April 14, 2019
• First Posted: August 5, 2020
• Study Start: October 1, 2015
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: within a year
• Access Criteria: on a reasonable request

Locations

PL (1)