Regional Anesthesia MorbidityNCT05706688
Effect of Regional Versus General Anesthesia on Thirty-day Outcomes Following Carotid Endarterectomy: a Matched-pairs Cohort Study.
An observational study of Regional Anesthesia Morbidity and Carotid Artery Diseases, run by University of Virginia.
Trial summary
The goal of this observational study is to assess the effect of regional versus general anesthesia on carotid endarterectomy thirty-day outcomes. The main questions it aims to answer are: Is regional anesthesia associated with lower incidence of major morbidity and mortality? Is regional anesthesia associated with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia Morbidity, Carotid Artery Diseases, Perioperative/Postoperative Complications
- What is being tested?
- Anesthetic technique (regional versus general)
- Type of treatment
- Surgery or procedure
- How many people
- 37,204 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elective carotid endarterectomy patients, ACS-NSQIP 2015-2019
Who may be able to join
- Elective, non-emergent cases
- Regional anesthesia
- General anesthesia
Who cannot join
- Concurrency in procedures
- Acute kidney injury (preoperative)
- End-stage renal disease (preoperative)
- Metastatic disease (preoperative)
- Wound infection (preoperative)
- Sepsis (preoperative)
- ASA 5
About this study
The goal of this observational study is to assess the effect of regional versus general anesthesia on carotid endarterectomy thirty-day outcomes. The main questions it aims to answer are:
- Is regional anesthesia associated with lower incidence of major morbidity and mortality?
- Is regional anesthesia associated with lower incidences of secondary adverse events?
Participants will be sampled from the 2015-2019 American College of Surgeons National Surgical Quality Improvement Program
- Conditions
- Regional Anesthesia Morbidity, Carotid Artery Diseases, Perioperative/Postoperative Complications
- Being tested
- Anesthetic technique (regional versus general)
- Medical subject headings
- Carotid Artery Diseases, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthetic technique (regional versus general)Procedure or surgery
Anesthetic technique (regional versus general)
| Study group | Role | What they receive |
|---|---|---|
| Regional anesthesia | 4,152 patients undergoing elective carotid endarterectomy under regional anesthesia Receives: Procedure: Anesthetic technique (regional versus general) | |
| General anesthesia | 4,152 matched controls undergoing elective carotid endarterectomy under general anesthesia Receives: Procedure: Anesthetic technique (regional versus general) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major morbidity and mortality
Stoke, myocardial infarction, or death
Measured: Thirty days
Secondary outcomes (4)
Minor morbidity
Reintubation, prolonged (>48 hour) ventilator dependence, pneumonia, deep venous thrombosis, pulmonary embolism, superficial surgical site infection (SSI), deep incisional SSI, organ space SSI, wound dehiscence, sepsis, septic shock, acute kidney injury, and progressive renal insufficiency
Measured: Thirty days
Bleeding events
Requiring transfusion
Measured: Thirty days
Unplanned resource utilization
Unplanned readmission and unplanned reoperation
Measured: Thirty days
Mortality
Mortality
Measured: Thirty days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Jan 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Regional Anesthesia MorbidityStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 37,204 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyi Zuo, MD, University of Virginia
- Investigators
- Zhiyi Zuo, MD, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706688
- Sponsor's protocol ID
- HSRZOKZZ
- Status last verified
- Jan 2023
- First submitted
- 21 Jan 2023
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: American College of Surgeons National Surgical Quality Improvement Program and the hospitals participating in the ACS NSQIP are the source of the data used herein. The Participant Use Data File (PUF) is a Health Insurance Portability and Accountability Act (HIPAA)-compliant data file containing cases submitted to the American College of Surgeons National Surgical Quality Improvement Program®. To request a copy of the PUF, individuals (data recipients) must agree to comply with the terms and conditions set forth in the Data Use Agreement, provide contact information, and complete a short online questionnaire. Once the information provided by the data recipient is received and processed by ACS NSQIP staff, a website address will be submitted electronically to the data recipient. The data recipient will then have 10 days (240 hours) to visit the website and download the data file.
Publications
Kline LA, Kothandaraman V, Knio ZO, Zuo Z. Effect of regional versus general anesthesia on thirty-day outcomes following carotid endarterectomy: a cohort study. Int J Surg. 2023 May 1;109(5):1291-1298. doi: 10.1097/JS9.0000000000000356.
PubMed 37057905
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Regional Versus General Anesthesia on Thirty-day Outcomes Following Carotid Endarterectomy: a Matched-pairs Cohort Study.
- ClinicalTrials.gov ID
- NCT05706688
- Acronym / sponsor ID
- HSRZOKZZ
- Conditions
- Regional Anesthesia Morbidity, Carotid Artery Diseases, Perioperative/Postoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37,204 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to assess the effect of regional versus general anesthesia on carotid endarterectomy thirty-day outcomes. The main questions it aims to answer are:
- Is regional anesthesia associated with lower incidence of major morbidity and mortality?
- Is regional anesthesia associated with lower incidences of secondary adverse events?
Participants will be sampled from the 2015-2019 American College of Surgeons National Surgical Quality Improvement Program
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional anesthesia | – | Procedure: Anesthetic technique (regional versus general)4,152 patients undergoing elective carotid endarterectomy under regional anesthesia |
| General anesthesia | – | Procedure: Anesthetic technique (regional versus general)4,152 matched controls undergoing elective carotid endarterectomy under general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elective carotid endarterectomy patients, ACS-NSQIP 2015-2019
Key inclusion criteria (3 listed)
- Elective, non-emergent cases
- Regional anesthesia
- General anesthesia
Key exclusion criteria (7 listed)
- Concurrency in procedures
- Acute kidney injury (preoperative)
- End-stage renal disease (preoperative)
- Metastatic disease (preoperative)
- Wound infection (preoperative)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthetic technique (regional versus general)Anesthetic technique (regional versus general) | Procedure or surgery | General anesthesia, Regional anesthesia |
Primary outcome
Major morbidity and mortality
Time frame: Thirty days
Stoke, myocardial infarction, or death
4 secondary outcomes
Minor morbidity
Time frame: Thirty days
Bleeding events
Time frame: Thirty days
Unplanned resource utilization
Time frame: Thirty days
Mortality
Time frame: Thirty days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Derived from this study: PubMed 37057905Kline LA, Kothandaraman V, Knio ZO, Zuo Z. Effect of regional versus general anesthesia on thirty-day outcomes following carotid endarterectomy: a cohort study. Int J Surg. 2023 May 1;109(5):1291-1298. doi: 10.1097/JS9.0000000000000356.
- Individual participant dataSharing planned: Yes. American College of Surgeons National Surgical Quality Improvement Program and the hospitals participating in the ACS NSQIP are the source of the data used herein. The Participant Use Data File (PUF) is a Health Insurance Portability and Accountability Act (HIPAA)-compliant data file containing cases submitted to the American College of Surgeons National Surgical Quality Improvement Program®. To request a copy of the PUF, individuals (data recipients) must agree to comply with the terms and conditions set forth in the Data Use Agreement, provide contact information, and complete a short online questionnaire. Once the information provided by the data recipient is received and processed by ACS NSQIP staff, a website address will be submitted electronically to the data recipient. The data recipient will then have 10 days (240 hours) to visit the website and download the data file.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiyi Zuo, MD, PhD principal investigator
University of Virginia
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Anesthesia Morbidity and Carotid Artery Diseases, run by University of Virginia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major morbidity and mortality (time frame: Thirty days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05706688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.