NCT05706688

Brief 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 lower incidences of secondary adverse events? Participants will be sampled from the 2015-2019 American College of Surgeons National Surgical Quality Improvement Program

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37,204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

5 years

First QC Date

January 21, 2023

Last Update Submit

January 21, 2023

Conditions

Regional Anesthesia MorbidityCarotid Artery DiseasesPerioperative/Postoperative Complications

Outcome Measures

Primary Outcomes (1)

  • Major morbidity and mortality

    Stoke, myocardial infarction, or death

    Thirty days

Secondary Outcomes (4)

  • Minor morbidity

    Thirty days

  • Bleeding events

    Thirty days

  • Unplanned resource utilization

    Thirty days

  • Mortality

    Thirty days

Study Arms (2)

Regional anesthesia

4,152 patients undergoing elective carotid endarterectomy under regional anesthesia

Procedure: Anesthetic technique (regional versus general)

General anesthesia

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

Procedure: Anesthetic technique (regional versus general)

Interventions

Anesthetic technique (regional versus general)PROCEDURE

Anesthetic technique (regional versus general)

General anesthesiaRegional anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elective carotid endarterectomy patients, ACS-NSQIP 2015-2019

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 37057905DERIVED

MeSH Terms

Conditions

Carotid Artery DiseasesPostoperative Complications

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zhiyi Zuo, MD, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2023

First Posted

January 31, 2023

Study Start

January 1, 2015

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

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.

Available IPD Datasets

Individual Participant Data Set Access