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

Completed

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

• Registration Number: NCT05706688
• Lead Sponsor: University of Virginia

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2023-01
• Study First Submitted: 2023-01-21
• Study First Submitted QC: 2023-01-21
• Last Update Submitted: 2023-01-21
• Study First Posted: 2023-01-31
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37204

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Regional anesthesia	Anesthetic technique (regional versus general)	4,152 patients undergoing elective carotid endarterectomy under regional anesthesia
General anesthesia	Anesthetic technique (regional versus general)	4,152 matched controls undergoing elective carotid endarterectomy under general anesthesia

Primary Outcome Measures

Name	Time	Method
Major morbidity and mortality	Thirty days	Stoke, myocardial infarction, or death

Secondary Outcome Measures

Name	Time	Method
Bleeding events	Thirty days	Requiring transfusion
Minor morbidity	Thirty days	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
Unplanned resource utilization	Thirty days	Unplanned readmission and unplanned reoperation
Mortality	Thirty days	Mortality