Overview

Co-administration of Dexmedetomidine in Carotid Endarterectomy (CEA)

Status:
Completed
Trial end date:
2020-12-04
Target enrollment:
0
Participant gender:
All
Summary
All neurosurgical patients at the Neurosurgery University Hospital Bern who will be operated for carotid endarterectomy (CEA) are routinely operated in deep anae¬sthesia with suppression of the electrical activity of the electroencephalogram (EEG). To achieve this suppression of the EEG activity (burst suppression, BS) high effector concentrations (Cet) of Propofol doses are needed. However, a protracted infusion of large amounts of Propofol to reach a BS during the operation can lead to accumulation and a protracted wake-up phase with poorer neurological assessability. Somatosensory evoked potentials (SSEP), and trans-cranial Doppler flow velocity in the middle cerebral artery are measured to detect ischemia until the operation. The SSEPs are used to verify the functional integrity of the nervous system in combination of the EEG and both together exclude severe global ischemia during the operation. The central acting α2-agonist Dexmedetomidine could help to reduce the amount of Propofol without influencing electrophysical studies. However, no data are currently known for practical use in carotid endarterectomy with Propofol with co-administration of Dexmedetomidine in conjunction with electrophysiological studies (SSEPs and MEPs).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital Inselspital, Berne
Treatments:
Dexmedetomidine
Criteria
Inclusion criteria are:

- Age ≥18 years

- ASA physical status 1-4

- written informed consent provided.

Exclusion Criteria:

- Age <18 years

- higher grade atrioventricular block without pacemaker

- severe hypovolaemia or bradycardia

- uncontrolled hyper- or hypotension

- hypersensibility concerning the active substance dexmedetomidine or any other
component

- serve liver disease

- known malignant hyperthermia

- cardiovascular instability or severe heart failure (> NYHA III)

- limited peripheral autonomic activity

- pregnancy

- rejection or lack of consent of the patient or their relatives.