Local anesthesia for carotid artery surgery

ISRCTN	ISRCTN42875310
DOI	https://doi.org/10.1186/ISRCTN42875310
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Euregio-Klinik
Funder	Euregio-Klinik

Submission date: 04/12/2023
Registration date: 08/02/2024
Last edited: 03/11/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Carotid endarterectomy (CEA) is a surgical procedure designed to treat carotid artery disease, specifically the narrowing or stenosis of the carotid arteries (internal carotid stenosis), which are major blood vessels in the neck that supply blood to the brain. The goal of the procedure is to remove the atherosclerotic plaque that has built up within the carotid artery and to restore normal blood flow to the brain.
This study examines the effectiveness of plexus anesthesia versus general anesthesia for carotid endarterectomy procedures. We have adopted plexus anesthesia as our primary approach since January 2023, and this study presents a detailed evaluation of the initial 50 consecutive cases. We carefully considered both advantages and potential drawbacks to assess the long-term viability of plexus anesthesia for patients with significant and symptomatic carotid stenosis. Additionally, we provide insights into the patients' perspectives and experiences during carotid endarterectomy under plexus anesthesia.

Who can participate?
Patients aged over 18 years with symptomatic internal carotid stenosis

What does the study involve?
Death rates, serious adverse (neurological) events, complications and conversions of plexus anesthesia are collected from electronic patient files.

What are the possible benefits and risks of participating?
This is a retrospective study so there is no further burden for the participants. All data are anonymized and encoded.

Where is the study run from?
Euregio-Klinik (Germany)

When is the study starting and how long is it expected to run for?
December 2023 to October 2025

Who is funding the study?
Euregio-Klinik (Germany)

Who is the main contact?
1. Ahmed Algharib, ahmed.algharib@euregio-klinik.de
2. Dr Giel G. Koning, giel.koning@euregio-klinik.de

Contact information

Mr Ahmed Algharib
Public, Scientific

Albert-Schweitzerstrasse 10
Nordhorn
48527
Germany

ORCID ID	0009-0002-2745-0944
Phone	+49 (0) 5921/841641
Email	ahmed.algharib@euregio-klinik.de

Dr Giel G. Koning
Principal investigator

Albert-Schweitzerstrasse 10
Nordhorn
48527
Germany

ORCID ID	0009-0001-9112-5313
Phone	+49 (0) 5921/841641
Email	giel.koning@euregio-klinik.de

Study information

Primary study design	Observational
Study design	Retrospective consecutive case series
Secondary study design	Case series
Study type	Participant information sheet
Scientific title	Plexus anesthesia introduced as the standard technique for carotid endarterectomy in a regional teaching hospital: the first 50 consecutive cases
Study objectives	Is introduction of plexus anesthesia for carotid endarterectomy patients in a regional teaching hospital possible within literature based complication rates?
Ethics approval(s)	Ethics approval not required
Ethics approval additional information	The board of the Ärztekammer Niedersachsen, Hannover, Germany have stated that no further ethical permission is needed for this study as the data collected has been anonymized in such a way that the person concerned cannot or can no longer be identified
Health condition(s) or problem(s) studied	Plexus anesthesia for carotid endarterectomy patients
Intervention	All symptomatic carotid endarterectomy patients are already operated on and encoded, all pre-, peri- and postoperative data codes will be used. Data is accessible in electronic patient files after informed consent of the Medical Ethical Board in Hannover has been obtained.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	1. Mortality collected from electronic patient files from operation date (in 2023) to 31/10/2023 2. Serious adverse (neurological) events collected from electronic patient files from operation date (in 2023) to 31/10/2023
Key secondary outcome measure(s)	Complications and conversions of plexus anesthesia collected from electronic patient files from operation date to 31/10/2023
Completion date	01/10/2025

Eligibility

Participant type(s)	Health professional, Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	50
Key inclusion criteria	1. Symptomatic internal carotid stenosis (>50%) 2. Adult (>18 years)
Key exclusion criteria	Previous ipsilateral internal carotid stenosis
Date of first enrolment	01/01/2023
Date of final enrolment	31/10/2023

Locations

Countries of recruitment

Germany

Study participating centre

Euregio Hospital

Albert-Schweitzerstrasse 10
Nordhorn
48527
Germany

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Not expected to be made available, Stored in non-publicly available repository
IPD sharing plan	IPD storage in a non-public and password-accessible computer. The datasets generated during and/or analysed during the current study are not expected to be made available due to the privacy laws in Germany. Moreover, the codes are not traceable to real patient data anymore after this was double-checked.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

28/02/2025: The overall study end date was changed from 01/10/2024 to 01/10/2025.
09/01/2025: The intention to publish date was changed from 31/12/2024 to 30/06/2025.
05/07/2024: The following changes were made:
1. The overall study end date was changed from 01/08/2024 to 01/10/2024.
2. The intention to publish date was changed from 01/07/2024 to 31/12/2024.
26/01/2024: Study's existence confirmed by the Ärztekammer Niedersachsen.