Effect of Dexmedetomidine on Hemodynamic Stability in Carotid Endarterectomy: Reduced Norepinephrine Use and Propofol Dosing Via Central Sympatholytic Action

NCT07597109 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025-00592
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Objective and Selection We refer to our research project as the "research project" in this information sheet. If you participate, you will be a participant.
2. 2.General Information Due to your narrowing of the carotid artery, you require a planned procedure under general anesthesia. During this, your circulatory system and heart function will be continuously monitored through ongoing measurements to constantly track your condition. At the start of general anesthesia, heart rate, blood oxygen levels, and blood pressure will be monitored. Strong painkillers and anesthetic agents will then be administered for the general anesthesia. Additional medications will be given to maintain the anesthesia. Your condition will be closely and continuously monitored throughout the general anesthesia. At the end of the surgery, the anesthetic agents will be gradually reduced, allowing you to awaken from the anesthesia. In this context, we want to examine whether the additional administration of dexmedetomidine during carotid artery surgery reduces blood pressure fluctuations that may occur during such anesthesia.
3. 3.Procedure The planned surgery will be performed independently of this study. Upon the patient's arrival in the operating room, they will be randomly assigned to one of two groups. One group will serve as the control group and receive standard general anesthesia according to our current hospital guidelines. The second group will receive the standard anesthesia plus the study medication dexmedetomidine in a precisely defined dose. Group allocation will be randomized and blinded (not disclosed to participants). The number of patients in both groups will be equal. Both groups will be treated and monitored in accordance with the recommendations and standards of the Department of Anesthesia and Pain Medicine at Inselspital Bern, as well as those of the Swiss Society for Anaesthesiology and Perioperative Medicine (SSAPM). Hemodynamic and cardiac function parameters will be closely monitored and recorded for all study participants. These data will be collected by the attending anesthesiologist.

Conditions

Steno-occlusive Disease

Outcome Measures

Primary Outcomes (1)

• Primary study outcome

  Primary study outcome are to evaluate the dose of Noradrenaline during CEA with EEG burst suppression (measured and interpreted by the anaesthes¬iologist) for the co-administration of Dexmedetomidine in combination with Propofol compared to Propofol alone as the standard therapy.

  2 years

Study Arms (2)

Co-Administration of Dexmedetomidine

EXPERIMENTAL

the participant in this group will recieve the standard anaesthesia care and in addition dexmedetomidine, First with a bolus of 0.4üg/kg over 10 min and then with a perfusor 0.4üg/kg/h during the hole operation

Drug: dexmedetomidine to the standard treatment

control group

OTHER

the control group recieve the standard medical care during th operation

Other: Standard anaesthesia with propofol with co-administration of Dexmedetomidine and Propofol with Dexmedetomidine (bolus 0.4 mcg/kg over 10 minutes followed by an continuous infusion with 0.4 mcg/kg/h un

Interventions

dexmedetomidine to the standard treatment DRUG

Standard anaesthesia with propofol with co-administration of Dexmedetomidine and Propofol with Dexmedetomidine (bolus 0.4 mcg/kg over 10 minutes followed by an continuous infusion with 0.4 mcg/kg/h until burst suppression will be reached) in conjunction with electrophysiological studies (somatosensory evoked potentials (SSEPs) and motor evoked potentials (MEPs))

Co-Administration of Dexmedetomidine

Standard anaesthesia with propofol with co-administration of Dexmedetomidine and Propofol with Dexmedetomidine (bolus 0.4 mcg/kg over 10 minutes followed by an continuous infusion with 0.4 mcg/kg/h un OTHER

Standard anaesthesia with Propofol in conjunction with electrophysiological studies (somatosensory evoked potentials (SSEPs) and motor evoked potentials (MEPs)).

control group

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, Rapid sequence induction needed for surgery, 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 (EF ≤ 30% or \> NYHA III), limited peripheral autonomic activity, pregnancy, rejection or lack of consent of the patient.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

MeSH Terms

Interventions

Propofol; Dexmedetomidine; United Nations

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; International Agencies; Organizations; Health Care Economics and Organizations

Central Study Contacts

Christian cv Vetter, MD

CONTACT

(0) 31 664 37 76; christian.vetter@insel.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: during the operation the praticipant will recieve dexmedetomidine or not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study, the control group will receive the standardtherapy and the verum group will recieve additionally dexmedetomidine

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 30, 2028
• Last Updated: May 19, 2026

Record last verified: 2025-05