SPI-guided Analgesia During CEA Under RA (CEA)

July 31, 2020 updated by: Michał Stasiowski, Medical University of Silesia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Silesia
      • Sosnowiec, Silesia, Poland, 41-200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPB
cervical plexus block was performed with 0,5% bupivacaine using Moore's technique
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.
Other Names:
  • rescue LA
Drug: rescue IA
in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist
Drug: 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
Drug: 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
Drug: rescue antyhypotensive medication
in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist
Drug: rescue antyhypotensive medication
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
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.
Other Names:
  • rescue LA
Drug: rescue IA
in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist
Drug: 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
Drug: 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
Drug: rescue antyhypotensive medication
in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist
Drug: rescue antyhypotensive medication
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
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.
Other Names:
  • rescue LA
Drug: rescue IA
in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist
Drug: 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
Drug: 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
Drug: rescue antyhypotensive medication
in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist
Drug: rescue antyhypotensive medication
in the case of intraoperative bradycardia, rescue intravenous antihypotensive medication using 500 mcg of atropine will be administered by anaesthesiologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
haemodynamic stability
Time Frame: intraoperatively
variations of haemodynamic parametres will be analysed
intraoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain perception using SPI value variations
Time Frame: intraoperatively
pain perception using SPI value variations will be analysed
intraoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
ischaemic stroke
Time Frame: from beginning of operation till discharge from hospital
presence of ischaemic stroke will be observed
from beginning of operation till discharge from hospital
dysarthria
Time Frame: from beginning of operation till discharge from hospital, approximately 2 - 14 days
presence of dysarthria will be observed
from beginning of operation till discharge from hospital, approximately 2 - 14 days
limb paresis
Time Frame: 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
hoarseness
Time Frame: 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
face semiparesis
Time Frame: from beginning of operation till discharge from hospital, approximately 2 - 14 days
presence of semiparesis will be observed
from beginning of operation till discharge from hospital, approximately 2 - 14 days
postoperative nausea and vomitting
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Collaborators

Silesian University of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

April 14, 2019

First Submitted That Met QC Criteria

July 31, 2020

First Posted (Actual)

August 5, 2020

Study Record Updates

Last Update Posted (Actual)

August 5, 2020

Last Update Submitted That Met QC Criteria

July 31, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SilesianMUKOAiIT4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

publication in AiIT

IPD Sharing Time Frame

within a year

IPD Sharing Access Criteria

on a reasonable request

IPD Sharing Supporting Information Type

  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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