Local anesthesia for carotid artery surgery
| ISRCTN | ISRCTN42875310 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42875310 |
- Submission date
- 04/12/2023
- Registration date
- 08/02/2024
- Last edited
- 28/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
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
Public, Scientific
Albert-Schweitzerstrasse 10
Nordhorn
48527
Germany
 ORCID ID |
0009-0002-2745-0944 |
|---|---|
| Phone | +49 (0) 5921/841641 |
| ahmed.algharib@euregio-klinik.de |
Principal Investigator
Albert-Schweitzerstrasse 10
Nordhorn
48527
Germany
| ORCID ID |
0009-0001-9112-5313 |
|---|---|
| Phone | +49 (0) 5921/841641 |
| giel.koning@euregio-klinik.de |
Study information
| Study design | Retrospective consecutive case series |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Other, Quality of life, Efficacy |
| Participant information sheet | Not applicable (retrospective study) |
| 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 | 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 |
| Secondary outcome measures | Complications and conversions of plexus anesthesia collected from electronic patient files from operation date to 31/10/2023 |
| Overall study start date | 01/12/2023 |
| Completion date | 01/10/2025 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 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
Nordhorn
48527
Germany
Sponsor information
Hospital/treatment centre
Albert Schweitzerstrasse 10
Nordhorn
48527
Germany
| Phone | +49 (0) 5921841641 |
|---|---|
| Ruediger.moeller@euregio-klinik.de | |
| Website | https://www.euregio-klinik.de |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed vascular surgery journal. The findings will be presented following the guidelines outlined in the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement, which offers a structured framework for reporting observational studies. |
| 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. |
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.
