Co-administration of Dexmedetomidine in Carotid Endarterectomy (CEA)

NCT04662177 | Completed Phase 4

• 1 other identifier: 2018-00220
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Carotid Stenosis

Outcome Measures

Primary Outcomes (1)

• Effect size concentration of propofol.

  The primary study outcome is to determine whether the intervention reduces the effect size concentration of propofol.

  until the operation

Secondary Outcomes (1)

• intraoperative propofol requirement

  until the operation

Study Arms (2)

Group 1: Co-administration of dexmedetomidine and propofol with electrophysiological studies

EXPERIMENTAL

The group 1 starts with a bolus of dexmedetomidine 0.4 µg/kg over 10 minutes, followed by continuous infusion of dexmedetomidine 0.4 µg/kg/h until the end of burst suppression.

Drug: Dexmedetomidine

Group 2: Standard anaesthesia with propofol and electrophysiological studies

NO INTERVENTION

The group 2 receive standard anaesthesia management.

Interventions

Dexmedetomidine DRUG

The study participants are divided into two groups: Group 1 starts with a bolus of dexmedetomidine 0.4 µg/kg over 10 minutes, followed by con-tinuous infusion of dexmedetomidine 0.4 µg/kg/h until the end of burst suppression. Group 2 receives the standard anaesthesia management.

Also known as: Dexdor(R), Dexmedetomidine

Group 1: Co-administration of dexmedetomidine and propofol with electrophysiological studies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• ASA physical status 1-4
• written informed consent provided.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

• Vetter C, Meyer ER, Seidel K, Bervini D, Huber M, Krejci V. Co-administration of dexmedetomidine with total intravenous anaesthesia in carotid endarterectomy reduces requirements for propofol and improves haemodynamic stability: A single-centre, prospective, randomised controlled trial. Eur J Anaesthesiol. 2025 Mar 1;42(3):255-264. doi: 10.1097/EJA.0000000000002099. Epub 2024 Nov 11.

  PMID: 39529482 DERIVED

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Christian cv Vetter, MD

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomised controlled prospective trial in two groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled prospective trial in two groups. Group 1 will receive anaesthesia with propofol and co-administration of dexmedetomidine in conjunction with electrophysiological studies measuring somatosensory evoked potentials (SSEPs) and motor evoked potentials (MEPs). Group 2 will receive standard anaesthesia with propofol alone, in conjunction with electro¬physio¬logical studies measuring SSEPs and MEPs.

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 10, 2020
• Study Start: November 21, 2018
• Primary Completion: October 16, 2020
• Study Completion: December 4, 2020
• Last Updated: December 19, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)