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

Perioperative/Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05706688
• Other study ID #: HSRZOKZZ
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2023
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 lower incidences of secondary adverse events?

Participants will be sampled from the 2015-2019 American College of Surgeons National Surgical Quality Improvement Program

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37204
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Artery Diseases
• Perioperative/Postoperative Complications
• Postoperative Complications
• Regional Anesthesia Morbidity

Intervention

Procedure:
• Anesthetic technique (regional versus general)
Anesthetic technique (regional versus general)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major morbidity and mortality	Stoke, myocardial infarction, or death	Thirty days
Secondary	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
Secondary	Bleeding events	Requiring transfusion	Thirty days
Secondary	Unplanned resource utilization	Unplanned readmission and unplanned reoperation	Thirty days
Secondary	Mortality	Mortality	Thirty days