SPI-guided Analgesia During CEA Under RA

Carotid Artery Stenoses Clinical Trial

— CEA  

Official title:

SPI-guided Analgesia in Patients Undergoing Carotid Endarterectomy Under Cervical Plexus Block

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04500249
• Other study ID #: SilesianMUKOAiIT4
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: October 1, 2020

Study information

• Verified date: July 2020
• Source: Medical University of Silesia
• Contact: Michal J Stasiowski, M.D
• Phone: 696797922
• Email: mstasiowski.anest[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 undergoing carotid endarterectomy under cervical plexus block.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carotid Artery Stenoses
• Carotid Stenosis

Intervention

Drug:
• infiltration rescue intraoperative analgesia
in the case of intraoperative pain perception, rescue infiltration analgesia using 1 % lidocaine administered by the operator into the operation field.
• rescue IA
in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist
• rescue 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
• rescue antyemetic medication
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
in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist
• rescue antyhypotensive medication
in the case of intraoperative bradycardia, rescue intravenous antihypotensive medication using 500 mcg of atropine will be administered by anaesthesiologist

Locations

Country	Name	City	State
Poland	Medical University of Silesia	Sosnowiec	Silesia

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Silesia	Silesian University of Medicine

Country where clinical trial is conducted

Poland, 

References & Publications (11)

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 pr — View Citation

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 — View Citation

Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Höcker 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. — View Citation

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. Review. — View Citation

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 — View Citation

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 (Toky — View Citation

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. — View Citation

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. do — View Citation

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 — View Citation

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). — View Citation

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ischaemic stroke	presence of ischaemic stroke will be observed	from beginning of operation till discharge from hospital
Other	dysarthria	presence of dysarthria will be observed	from beginning of operation till discharge from hospital, approximately 2 - 14 days
Other	limb paresis	presence of limb paresis will be observed	from beginning of operation till discharge from hospital, approximately 2 - 14 days
Other	hoarseness	presence of hoarseness will be observed	from beginning of operation till discharge from hospital, approximately 2 - 14 days
Other	face semiparesis	presence of semiparesis will be observed	from beginning of operation till discharge from hospital, approximately 2 - 14 days
Other	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
Primary	haemodynamic stability	variations of haemodynamic parametres will be analysed	intraoperatively
Secondary	pain perception using SPI value variations	pain perception using SPI value variations will be analysed	intraoperatively