SPI-guided Analgesia During CEA Under RA

Medical University of Silesia

Status: Unknown

Conditions: Carotid Artery Stenoses

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04500249

SilesianMUKOAiIT4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 3 patient groups

CPB

Experimental group

Description:

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

Treatment:

Drug: rescue IA

Drug: rescue antyemetic medication

Drug: rescue antyhypertensive medication

Drug: rescue antyhypotensive medication

Drug: rescue antyhypotensive medication

Drug: infiltration rescue intraoperative analgesia

CPB with SPI guided analgesia

Experimental group

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

Treatment:

Drug: rescue IA

Drug: rescue antyemetic medication

Drug: rescue antyhypertensive medication

Drug: rescue antyhypotensive medication

Drug: rescue antyhypotensive medication

Drug: infiltration rescue intraoperative analgesia

CPB plus SPI guided analgesia plus carotid artery block

Experimental group

Description:

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

Treatment:

Drug: rescue IA

Drug: rescue antyemetic medication

Drug: rescue antyhypertensive medication

Drug: rescue antyhypotensive medication

Drug: rescue antyhypotensive medication

Drug: infiltration rescue intraoperative analgesia