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

Study Overview

• Status: Completed
• Conditions: Carotid Artery Diseases; Perioperative/Postoperative Complications; Regional Anesthesia Morbidity
• Intervention / Treatment: Procedure: Anesthetic technique (regional versus general)

• Study Type: Observational
• Enrollment (Actual): 37204

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Elective carotid endarterectomy patients, ACS-NSQIP 2015-2019

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Regional anesthesia; 4,152 patients undergoing elective carotid endarterectomy under regional anesthesia	Procedure: Anesthetic technique (regional versus general); Anesthetic technique (regional versus general)
General anesthesia; 4,152 matched controls undergoing elective carotid endarterectomy under general anesthesia	Procedure: Anesthetic technique (regional versus general); Anesthetic technique (regional versus general)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major morbidity and mortality	Stoke, myocardial infarction, or death	Thirty days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Thirty days
Bleeding events	Requiring transfusion	Thirty days
Unplanned resource utilization	Unplanned readmission and unplanned reoperation	Thirty days
Mortality	Mortality	Thirty days

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Zhiyi Zuo, MD, PhD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: January 21, 2023
• First Submitted That Met QC Criteria: January 21, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 21, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carotid Artery Diseases; Postoperative Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: HSRZOKZZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Study Data/Documents

1. Individual Participant Data Set
   Information comments: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No