drugset / Trial / NCT04662177

Co-administration of Dexmedetomidine in Carotid Endarterectomy (CEA)

NCT04662177 ↗

Phase 4 Completed 23 enrolled Insel Gruppe AG, University Hospital Bern
RandomizedParallel-groupSingle-blindTreatment

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).

Timeline

Start
2018-11-21
Primary completion
2020-10-16
Completion
2020-12-04

Outcome

Met primary endpoint

paper The effect-site concentration of propofol required for burst suppression was 4.0 μg ml -1 [3.50 to 4.90] (median [interquartile range]) in the dexmedetomidine group compared with 6.0 μg ml -1 PMID 39529482 ↗

paper ( P  < 0.001). PMID 39529482 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 0.4 ug/kg Intravenous

Indications