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SPI-guided Analgesia During CEA Under RA (CEA)

Primary Purpose

Carotid Artery Stenoses

Status

Unknown status

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

infiltration rescue intraoperative analgesia

rescue IA

rescue antyhypertensive medication

rescue antyemetic medication

rescue antyhypotensive medication

About this trial

This is an interventional treatment trial for Carotid Artery Stenoses focused on measuring Surgical Pleth Index (SPI), Cervical plexus block, Adequacy of Anaesthesia (AoA, State Entropy, Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical University of SilesiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

CPB

CPB with SPI guided analgesia

CPB plus SPI guided analgesia plus carotid artery block

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

haemodynamic stability

variations of haemodynamic parametres will be analysed

Secondary Outcome Measures

pain perception using SPI value variations

pain perception using SPI value variations will be analysed

Full Information

NCT ID

NCT04500249

First Posted

April 14, 2019

Last Updated

July 31, 2020

Sponsor

Medical University of Silesia

Collaborators

Silesian University of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04500249

Brief Title

SPI-guided Analgesia During CEA Under RA

Acronym

CEA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2015 (Actual)

Primary Completion Date

October 1, 2020 (Anticipated)

Study Completion Date

October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Silesia

Collaborators

Silesian University of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carotid Artery Stenoses

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Masking Description

neither participant nor operator is aware of rescue analgesia protocol

Allocation

Randomized

Enrollment

105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CPB

Arm Type

Experimental

Arm Description

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

Arm Title

CPB with SPI guided analgesia

Arm Type

Experimental

Arm Description

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

Arm Title

CPB plus SPI guided analgesia plus carotid artery block

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

infiltration rescue intraoperative analgesia

Other Intervention Name(s)

rescue LA

Intervention Description

in the case of intraoperative pain perception, rescue infiltration analgesia using 1 % lidocaine administered by the operator into the operation field.

Intervention Type

Drug

Intervention Name(s)

rescue IA

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

rescue antyhypertensive medication

Intervention Description

in the case of intraoperative hypertension reluctant to rescue analgesia, rescue intravenous antihypertensive medication using 10 mcg of urapidil will be administered by anaesthesiologist

Intervention Type

Drug

Intervention Name(s)

rescue antyemetic medication

Intervention Description

in the case of postoperative nausea and vomitting, rescue intravenous antiemetic medication using 4 mg of ondansetron will be administered by anaesthesiologist

Intervention Type

Drug

Intervention Name(s)

rescue antyhypotensive medication

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

rescue antyhypotensive medication

Intervention Description

in the case of intraoperative bradycardia, rescue intravenous antihypotensive medication using 500 mcg of atropine will be administered by anaesthesiologist

Primary Outcome Measure Information:

Title

haemodynamic stability

Description

variations of haemodynamic parametres will be analysed

Time Frame

intraoperatively

Secondary Outcome Measure Information:

Title

pain perception using SPI value variations

Description

pain perception using SPI value variations will be analysed

Time Frame

intraoperatively

Other Pre-specified Outcome Measures:

Title

ischaemic stroke

Description

presence of ischaemic stroke will be observed

Time Frame

from beginning of operation till discharge from hospital

Title

dysarthria

Description

presence of dysarthria will be observed

Time Frame