SPI-guided Analgesia During CEA Under RA

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

Interventions

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.

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

Sponsors & Collaborators

• Silesian University of Medicine

  collaborator OTHER

• Medical University of Silesia

  lead OTHER

Principal Investigators

• Michał J Stasiowski, M.D · Medical University of Silesia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-01

Primary Completion

2020-10-01

Completion

2020-10-01

Countries

• Poland

Study Locations