Dexmedetomidine During Carotid Endarterectomy: a Registry on Safety and Satisfaction of Patients and Operators (DexTEA)
Conditions: Hypertension Arterial, Desaturation, Bradycardia, Surgery (Major Vascular), Hypotension During Surgery, Dexmedetomidine Induced Sedation, Fentanyl Analgesia, Satisfaction, Patient, Satisfaction, Personal, Nausea/Vomiting
Sponsor: Saint Camillus International University of Health Sciences

 
 
 
 
 
 
 
 
Study Protocol and Statistical Analysis Plan (SAP) 
USE OF DEXMEDETOMIDINE DURING CAROTID ENDARTERECTOMY: SAFETY 
PROFILE, AND SATISFACTION OF THE PATIENT AND OPERATORS 
version II 8th November 2020 
Approved by local Ethics Committee on 10th February 2021 
(Protocol n. 0031200/2021) 
 
 
 
 
 
 
 
 
 
 
 
 

USE OF DEXMEDETOMIDINE DURING CAROTID ENDARTERECTOMY: SAFETY 
PROFILE, PATIENT AND OPERATORS SATISFACTION 
 
Version II of 08.11.2020 
 
INTRODUCTION 
Cervical plexus block provides anesthesia and analgesia for head and neck surgery [1-7], and this 
block is mainly performed for carotid endarterectomy (CEA) surgery [8-12]. The nomenclature of 
cervical plexus block is complex, and the classification follows the anatomical topography of the 
structures [13]. CEA surgery is the most frequent vascular surgery in the world, and represents the 
most effective medical approach in significantly reducing the risk of ischemic stroke in patients with 
high-grade carotid stenosis [14-18]. Recently, the GALA trial did not demonstrate the superiority of 
general or locoregional anesthesia in this type of intervention [19-21], with notable differences 
between the two techniques [22], including the risk of postoperative cognitive deterioration [23]. 
The intermediate cervical plexus block currently represents the gold standard, compared to the 
intermediate cervical plexus or the cervical epidural [24, 25], although new promising techniques are 
gaining ground such as the anterior approach [26], or the so-called C2-C4 compartment block [27]. 
Dexmedetomidine is a well-known superselective α2 agonist drug, with hypnotic, sedative, 
anxiolytic, sympatholytic and analgesic activity, suppressing the neuronal noradrenergic storm at the 
locus coeruleus [28], without inducing respiratory depression [29]. Dexmedetomidine has no rebound 
effects even after 24 hours of continuous infusion, therefore it is well suited to administration for 
short-duration procedures [30]. In association with other anesthetic drugs it reduces the dose required 
in the perioperative period. It has a good safety margin, especially in expert hands [31]. It has been 
shown to have the possibility of reducing the dose of Morphine required in the postoperative period 
[32], decreasing PONV in laparoscopic surgery [33], and its manageability has meant that it is used 

in outpatient ophthalmological surgery, gynecological surgery and intubation with optical fibers [34-
38]. 
It has been observed that the anteroposterior diameter of the pharynx at the level of the soft palate 
decreases after administration of Propofol alone [39], with associated motor dysfunction [40], while 
Dexmedetomidine amplifies it in patients with OSAS [41] and Dexmedetomidine is associated with 
a lower number of apneas during sedation in patients under subarachnoid anesthesia [42]. Better pain 
control and peripheral oxygen saturation level has been evaluated with Dexmedetomidine instead of 
Midazolam [43], at different doses (1y/kg for 15 minutes followed by 0.2 y/kg) were burdened by 
serious adverse events such as extreme bradycardia [44]. In another study, the infusion of 
Dexmedetomidine 1y/kg for 10 minutes plus Midazolam was evaluated without differences in 
alterations of vital functions, but with a decreased satisfaction of the patients at the end of the 
examination [45]. 
The implementation of Dexmedetomidine in the Vascular Surgery room could represent an additional 
weapon for the safety of the Patient undergoing Carotid Endarterectomy (CEA). In a randomized-
controlled study (RCT) on 64 patients undergoing CEA, the infusion of Dexmedetomidine at 1y/kg 
in 10 min, and then 0.2 y/kg/h, decreased the need for Urapidil and Fentanyl compared to the placebo 
group [46]. An RCT on 66 patients has shown that Dexmedetomidine during CEA decreases plasma 
levels of norepinephrine, fluctuations in sedation levels and the requirement for B-blockers in the 
intraoperative period [47], while another RCT shows a lower requirement for antihypertensives and 
analgesics in the group treated with Dexmedetomidine compared to the group treated with Fentanyl 
and Midazolam, but with a superiority that is not statistically significant [48]. In another retrospective 
study conducted by Do W et al, however, a lesser haemodynamic instability was seen in the group 
subjected to cervical plexus block + Dexmedetomidine compared to the group subjected to General 
Anesthesia [49]. 
Given the variability of the responses of vital parameters and dosages used in the literature, it would 
seem that there is not yet an “optimal dose” that can be used during CEA surgery. The positive data 

suggest that it is a drug of great utility in this area, but the use at sedoanalgesic doses, i.e. as when it 
is used in intensive care, does not seem to be suitable for environments such as the Operating Room. 
Furthermore, the level of satisfaction of the three main figures operating in the Operating Room 
(Patient, Anesthetist and Surgeon) in relation to the type of sedoanalgesia adopted has rarely been 
studied.  
The aim of this study is therefore to evaluate the safety of the use of the two anesthesiological 
techniques, and the response of the Patient, the Anesthetist and the Surgeon based on sedoanalgesia 
with Fentanyl + Midazolam, or with Dexmedetomidine. 
 
 
AIM OF THE STUDY 
OBSERVATIONAL LONGITUDINAL COHORT STUDY ON DRUGS 
To evaluate the usefulness of Dexmedetomidine during Carotid Endarterectomy. 
Primary endpoint: minor and major adverse events. 
Secondary endpoint: satisfaction of the Patient, the Anesthetist and the Surgeon (4=very satisfied, 
3=satisfied, 2=not very satisfied, 1=not satisfied), possible reduction in clamping times, number of 
times the Surgeon needs to administer local anesthesia (Lidocaine 0.5%). 
 
METHODS 
Patient selection 
All patients admitted to the Vascular Surgery Unit who are candidates for Carotid Endarterectomy 
will be considered eligible for the study. 
Patients with the following will be excluded: 
-Severe hepatic insufficiency or severe hypoproteinemia (increased percentage of free dexdor) 
-Age <18 years 
-Baseline heart rate < 50 bpm 

-BAV II or III without PMK 
-Reduced ANS activity 
-Suspected or confirmed malignant hyperthermia 
-Psychiatric disorders 
-Breastfeeding 
-Suspected or confirmed pregnancy 
-Urgent interventions 
-Inability to express valid consent to the procedure 
Anamnestic data, surgical time, clamping time, percentage of shunt and conversion to general 
anesthesia, intraprocedural complications and in the 4 hours postoperatively (e.g. severe bradycardia 
<40 bpm, SpO2 <85%, alterations in depth of consciousness) will be noted. 
Patients will be divided into two groups in relation to the type of sedation expected: 
Group 1 - standard sedation with Fentanyl 1y/kg + Midazolam 0.03 mg/kg 
Group 2 - sedation with Dexmedetomidine 1 y/kg/min for 10 minutes and then 0.3-0-5 y/kg/min until 
reaching a Richmond Agitation-Sedation Scale (RASS)=-1/-2. Both techniques are used in common 
clinical practice. 
The administration of drugs will always be carried out by the same Anesthetist. 
 
Patient monitoring 
All patients, after informed consent, will undergo Carotid Endarterectomy under continuous 
monitoring of cardiac, respiratory and neurological activities. Cardiac activity will be monitored by 
ECG while respiratory activity will be monitored by monitoring the respiratory acts with direct 
observation of the chest and evaluation of O2 saturation (SaO2) by pulse oximetry. A reduction in 
SaO2 <90% will be defined as a mild desaturation episode and <85% as a severe one, and they will 
be rebalanced ad hoc. Diastolic, systolic and mean blood pressure will be evaluated beat-by-beat via 
arterial catheter during the operation and in the Recovery Room. The heart rate will be assessed with 

a monitor and will be defined as mild bradycardia <50 bpm and severe <40 bpm, injection therapy 
with atropine (0.1 mg/kg) or other will be implemented if deemed necessary. At the end of the 
intervention, the patient will be monitored in the following 4 hours, and discharged according to the 
Aldrete’s criteria, reporting the times of discharge from the recovery room.  
 
STATISTICAL ANALYSIS 
Evaluation of data and results 
Since this is a preliminary study, it is not possible to perform a statistical calculation of the sample 
size due to the lack of statistics suitable for the purpose. It is planned to enroll 60 patients treated in 
common clinical practice, 30 treated with Fentanyl + Midazolam, and 30 with Dexmedetomidine. 
The two groups of patients will be compared based on the parameters evaluated. The statistical 
analysis will be performed using the chi-square or Fisher test for the comparison of proportions, and 
the Student t test for the comparison of means ± SD. 
 
 
 
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