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Effect of Regional Versus General Anesthesia on Thirty-day Outcomes Following Carotid Endarterectomy: a Matched-pairs Cohort Study.

NCT ID: NCT05706688

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2019-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Regional Anesthesia Morbidity Carotid Artery Diseases Perioperative/Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Regional anesthesia

4,152 patients undergoing elective carotid endarterectomy under regional anesthesia

Anesthetic technique (regional versus general)

Intervention Type PROCEDURE

Anesthetic technique (regional versus general)

General anesthesia

4,152 matched controls undergoing elective carotid endarterectomy under general anesthesia

Anesthetic technique (regional versus general)

Intervention Type PROCEDURE

Anesthetic technique (regional versus general)

Interventions

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Anesthetic technique (regional versus general)

Anesthetic technique (regional versus general)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Elective, non-emergent cases
* Regional anesthesia
* General anesthesia

Exclusion Criteria

* Concurrency in procedures
* Acute kidney injury (preoperative)
* End-stage renal disease (preoperative)
* Metastatic disease (preoperative)
* Wound infection (preoperative)
* Sepsis (preoperative)
* ASA 5
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Zhiyi Zuo, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhiyi Zuo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

References

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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.

Reference Type DERIVED
PMID: 37057905 (View on PubMed)

Study Documents

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Document Type: Individual Participant Data Set

View Document

Other Identifiers

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HSRZOKZZ

Identifier Type: -

Identifier Source: org_study_id