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

NCT07105527 | Completed

• 1 other identifier: 0002376
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

From an anesthesiological perspective, carotid endarterectomy (CEA) is an operation that is increasingly being performed with locoregional techniques and sedation. The aim of this observational study was to compare dexmedetomidine with midazolam and fentanyl during CEA in terms of perioperative adverse events, patient, anesthetist, and surgeon satisfaction, as well as the possible reduction in clamping time and the number of times additional local anaesthesia is needed. Sixty patients listed for CEA were enrolled and two types of sedation were used, both protocols widely used in our hospital, resulting in the formation of two groups of patients. Both the intermediate and superficial cervical plexus blocks were administered, and the patients in Group 1 were sedated with midazolam and fentanyl, and Group 2 was sedated with dexmedetomidine. The investigators examined comorbidities, surgical time and clamping, and possible intraoperative use of local anaesthetics and intraprocedural complications, and follow-up at 180 days to observe any residual deficits. The data were analysed with Statistical Package for Social Science (SPSS) Statistics 25 (IBM).

Conditions

Hypertension Arterial; Desaturation; Bradycardia; Surgery (Major Vascular); Hypotension During Surgery; Dexmedetomidine Induced Sedation; Fentanyl Analgesia; Satisfaction, Patient; Satisfaction, Personal; Nausea/Vomiting

Keywords

dexmedetomidine; cervical plexus block; sedation; satisfaction; humans; follow-up; prospective study; endarterectomy; clamping time; analgesic

Outcome Measures

Primary Outcomes (7)

• Patients, anaesthetists and surgeons' satisfaction

  evaluation on a graded scale from 1 to 4 (4=very satisfied, 3=satisfied, 2=slightly satisfied, 1=not satisfied),

  Periprocedural

• Number of Participants with Hypertension

  Systolic Blood Pressure\> 145 mmHg

  Periprocedural

• Number of Participants with Hypotension

  Systolic Blood Pressure \<100 mmHg

  Periprocedural

• Number of Participants with Bradycardia

  Heart Rate \<50 beats per minute

  Periprocedural

• Number of Participants with Nausea and/or Vomiting

  Number of events

  Periprocedural

• Number of Participants with Desaturation

  Hemoglobin saturation \<88%

  Periprocedural

• Number of Participants with Chronic surgical site pain

  Numerical Rating Scale (NRS): Zero is equivalent to no pain and 10 indicates the worst possible pain

  Up to 6 months

Secondary Outcomes (2)

• Change in clamping time

  Periprocedural

• Number of times the surgeon had to administer local anaesthesia

  Periprocedural

Study Arms (2)

sedation with 1 mcg/kg fentanyl + 0.03 mg/kg midazolam in boluses

until RASS -1/-2

sedation with dexmedetomidine 1 mcg/kg/h for 10 minutes and then 0.3-0.5 mcg/kg/h

until RASS -1/-2

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 anaesthetists 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

You may qualify if:

• Patients who were candidates for carotid endoarterectomy elective surgery
• Age \>18yr
• Ability to provide consent for the procedure

You may not qualify if:

• severe liver failure (Child-Pugh classes B or C) or severe hypoproteinemia (albuminemia \< 3.0 g/dl)
• age \<18yr
• baseline heart rate \<50 bpm; II or III grade atrioventricular block without a pacemaker
• malignant hyperthermia suspected or established
• psychiatric disorders
• emergency surgery
• inability to provide consent for the procedure

Sponsors & Collaborators

• Saint Camillus International University of Health Sciences: lead

Study Sites (1)

Sant'Eugenio Hospital

Roma, 00144, Italy

Location

Related Publications (21)

• Malek LA, Malek AK, Leszczynski J, Toutounchi S, Elwertowski M, Spiewak M, Domagala P. Carotid clamping time as a risk factor for early restenosis after carotid endarterectomy. Eur J Vasc Endovasc Surg. 2005 Aug;30(2):143-6. doi: 10.1016/j.ejvs.2005.04.023.

  PMID: 15936960 BACKGROUND

• Do W, Cho AR, Kim EJ, Kim HJ, Kim E, Lee HJ. Ultrasound-guided superficial cervical plexus block under dexmedetomidine sedation versus general anesthesia for carotid endarterectomy: a retrospective pilot study. Yeungnam Univ J Med. 2018 Jun;35(1):45-53. doi: 10.12701/yujm.2018.35.1.45. Epub 2018 Jun 30.

  PMID: 31620570 BACKGROUND

• McCutcheon CA, Orme RM, Scott DA, Davies MJ, McGlade DP. A comparison of dexmedetomidine versus conventional therapy for sedation and hemodynamic control during carotid endarterectomy performed under regional anesthesia. Anesth Analg. 2006 Mar;102(3):668-75. doi: 10.1213/01.ane.0000197777.62397.d5.

  PMID: 16492813 BACKGROUND

• Bekker AY, Basile J, Gold M, Riles T, Adelman M, Cuff G, Mathew JP, Goldberg JD. Dexmedetomidine for awake carotid endarterectomy: efficacy, hemodynamic profile, and side effects. J Neurosurg Anesthesiol. 2004 Apr;16(2):126-35. doi: 10.1097/00008506-200404000-00004.

  PMID: 15021281 BACKGROUND

• Sidorowicz M, Owczuk R, Kwiecinska B, Wujtewicz MA, Wojciechowski J, Wujtewicz M. Dexmedetomidine sedation for carotid endarterectomy. Anestezjol Intens Ter. 2009 Apr-Jun;41(2):78-83.

  PMID: 19697824 BACKGROUND

• Reel B, Maani CV. Dexmedetomidine. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK513303/

  PMID: 30020675 BACKGROUND

• Ramos-Matos CF, Bistas KG, Lopez-Ojeda W. Fentanyl. 2023 May 29. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459275/

  PMID: 29083586 BACKGROUND

• Dyck JB, Maze M, Haack C, Vuorilehto L, Shafer SL. The pharmacokinetics and hemodynamic effects of intravenous and intramuscular dexmedetomidine hydrochloride in adult human volunteers. Anesthesiology. 1993 May;78(5):813-20. doi: 10.1097/00000542-199305000-00002.

  PMID: 8098190 BACKGROUND

• Rahimzadeh P, Faiz SHR, Imani F, Derakhshan P, Amniati S. Comparative addition of dexmedetomidine and fentanyl to intrathecal bupivacaine in orthopedic procedure in lower limbs. BMC Anesthesiol. 2018 Jun 6;18(1):62. doi: 10.1186/s12871-018-0531-7.

  PMID: 29875020 BACKGROUND

• Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000 Mar;90(3):699-705. doi: 10.1097/00000539-200003000-00035.

  PMID: 10702460 BACKGROUND

• Nacif-Coelho C, Correa-Sales C, Chang LL, Maze M. Perturbation of ion channel conductance alters the hypnotic response to the alpha 2-adrenergic agonist dexmedetomidine in the locus coeruleus of the rat. Anesthesiology. 1994 Dec;81(6):1527-34. doi: 10.1097/00000542-199412000-00029.

  PMID: 7992922 BACKGROUND

• Rossel T, Kersting S, Heller AR, Koch T. Combination of high-resolution ultrasound-guided perivascular regional anesthesia of the internal carotid artery and intermediate cervical plexus block for carotid surgery. Ultrasound Med Biol. 2013 Jun;39(6):981-6. doi: 10.1016/j.ultrasmedbio.2013.01.002. Epub 2013 Mar 15.

  PMID: 23499343 BACKGROUND

• Ramachandran SK, Picton P, Shanks A, Dorje P, Pandit JJ. Comparison of intermediate vs subcutaneous cervical plexus block for carotid endarterectomy. Br J Anaesth. 2011 Aug;107(2):157-63. doi: 10.1093/bja/aer118. Epub 2011 May 24.

  PMID: 21613278 BACKGROUND

• Perisanidis C, Saranteas T, Kostopanagiotou G. Ultrasound-guided combined intermediate and deep cervical plexus nerve block for regional anaesthesia in oral and maxillofacial surgery. Dentomaxillofac Radiol. 2013;42(2):29945724. doi: 10.1259/dmfr/29945724. Epub 2012 Aug 29.

  PMID: 22933534 BACKGROUND

• Pandit JJ, Satya-Krishna R, Gration P. Superficial or deep cervical plexus block for carotid endarterectomy: a systematic review of complications. Br J Anaesth. 2007 Aug;99(2):159-69. doi: 10.1093/bja/aem160. Epub 2007 Jun 18.

  PMID: 17576970 BACKGROUND

• Heyer EJ, Gold MI, Kirby EW, Zurica J, Mitchell E, Halazun HJ, Teverbaugh L, Sciacca RR, Solomon RA, Quest DO, Maldonado TS, Riles TS, Connolly ES Jr. A study of cognitive dysfunction in patients having carotid endarterectomy performed with regional anesthesia. Anesth Analg. 2008 Aug;107(2):636-42. doi: 10.1213/ane.0b013e3181770d84.

  PMID: 18633045 BACKGROUND

• Zdrehus C. Anaesthesia for carotid endarterectomy - general or loco-regional? Rom J Anaesth Intensive Care. 2015 Apr;22(1):17-24.

  PMID: 28913451 BACKGROUND

• Hynes N, Sultan S. Carotid Surgery Is the Gold Standard for High-Risk (HRP) Carotid Artery Intervention: Five-Year Cost-Effectiveness and Quality Stroke-Free Survival Comparison Between Carotid Endarterectomy (CEA), Carotid Angioplasty, and Stenting Technique (CAST), and Optimal Medical Therapy (OMT). J Vasc Surg. 2011 Feb;53(2):558

  BACKGROUND

• GALA Trial Collaborative Group; Lewis SC, Warlow CP, Bodenham AR, Colam B, Rothwell PM, Torgerson D, Dellagrammaticas D, Horrocks M, Liapis C, Banning AP, Gough M, Gough MJ. General anaesthesia versus local anaesthesia for carotid surgery (GALA): a multicentre, randomised controlled trial. Lancet. 2008 Dec 20;372(9656):2132-42. doi: 10.1016/S0140-6736(08)61699-2. Epub 2008 Nov 27.

  PMID: 19041130 BACKGROUND

• Ferguson GG, Eliasziw M, Barr HW, Clagett GP, Barnes RW, Wallace MC, Taylor DW, Haynes RB, Finan JW, Hachinski VC, Barnett HJ. The North American Symptomatic Carotid Endarterectomy Trial : surgical results in 1415 patients. Stroke. 1999 Sep;30(9):1751-8. doi: 10.1161/01.str.30.9.1751.

  PMID: 10471419 BACKGROUND

• North American Symptomatic Carotid Endarterectomy Trial Collaborators; Barnett HJM, Taylor DW, Haynes RB, Sackett DL, Peerless SJ, Ferguson GG, Fox AJ, Rankin RN, Hachinski VC, Wiebers DO, Eliasziw M. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med. 1991 Aug 15;325(7):445-53. doi: 10.1056/NEJM199108153250701.

  PMID: 1852179 BACKGROUND

MeSH Terms

Conditions

Hypertension; Bradycardia; Patient Satisfaction; Personal Satisfaction; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Diego Fiume, MD PhD

  UniCamillus - Saint Camillus International University of Health and Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: August 6, 2025
• Study Start: January 8, 2021
• Primary Completion: February 2, 2023
• Study Completion: August 2, 2023
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)