Dexmedetomidine During Carotid Endarterectomy: a Registry on Safety and Satisfaction of Patients and Operators (DexTEA)

Carotid endarterectomy (CEA) is one of the most common procedures in vascular surgery, along with lower limb revascularization, and endovascular surgery. It has long been considered a standard for the treatment of carotid artery disease; it is currently considered the most valid medical approach for significantly decreasing the risk of ischemic stroke in symptomatic patients and a 'quasi standard' for the treatment in patients with high-grade carotid stenosis. From an anesthesiological perspective, it is a procedure than can be approached in different ways, i.e., with the patient under a state of general anaesthesia or with locoregional techniques (with possible sedation).

Although the recent General Anesthesia vs. Local Anesthesia (GALA) trial did not demonstrate the superiority of either of the above mentioned anaesthesiological management methods for this type of surgery, there are differences between the two techniques, including the risk of postoperative cognitive impairment.

Considering the type of surgery, for greater control of haemodynamic management without excessive hypotension or hypertension, at our Unit (Sant'Eugenio Hospital, Rome, Italy), the surgery is performed through the locoregional approach, sedating the patient only to keep it still during the procedure but awake to be able to evaluate haemodynamic compensation.

Under locoregional anaesthesia, a standard for anesthesia in this procedure is the intermediate cervical| plexus block. The cervical plexus block provides anaesthesia and analgesia for neck and head surgery, including CEA procedures. Usually, along with peripheral blockade, the use of hypnotics with a sedative dosage is preferred to increase patient compliance. There are numerous drugs used to sedate patients during a procedure, starting with the most widely used drugs, such as midazolam and propofol, followed by the most recently introduced drug, dexmedetomidine. The latter is a well-known superselective a2-agonist drug with hypnotic, sedative, anxiolytic, sympatholytic and analgesic activity that suppresses the neuronal noradrenergic cascade at the locus coeruleus level without inducing respiratory depression. It has no rebound effects even after 24 hours of continuous infusion and, therefore, lends itself well to administration even for short-term procedures. It also possesses a good safety margin. The purpose of this observational study is to compare the two major sedation techniques and protocols currently used and the usefulness of dexmedetomidine during carotid endarterectomy in terms of minor and major adverse events and patient, anaesthetist, and surgeon satisfaction, as well as the possible reduction in clamping time and the number of times the surgeon needs to administer additional local anaesthesia.

Study Design and Population A single-center, prospective observational study was conducted entirely within the Sant'Eugenio Hospital. All methods were performed in accordance with the guidelines and regulations of the Declaration of Helsinki, and this prospective observational study was approved by the Independent Ethics Committee of the Sant'Eugenio Hospital. Written informed consent was obtained from all patients whose data were collected. The minimum target set to start the study was the enrolment of 60 patients to be divided equally into two groups, since our group of anesthetists uses, without preference, two sedation protocols, in addition to cervical plexus blockade, for TEA operations in vascular surgery, both of which are approved in the literature and in internal hospital procedures. This process took place from January 2021 to December 2023. All patients referred to the Vascular Surgery of the hospital who were candidates for carotid endoarterectomy surgery were considered eligible for the study. The exclusion criteria included: severe liver failure (Child-Pugh classes B or C) or severe hypoproteinemia (albuminemia < 3.0 g/di); age <18 yr; baseline heart rate <50 bpm; Il or Ill grade atrioventricular block without a pacemaker; malignant hyperthermia suspected or established; psychiatric disorders; emergency surgery, inability to provide consent for tie procedure.