Effects of Anesthetics on Postoperative Cognitive Function of Patients Undergoing Endovascular Repair of Aortic Aneurysm and Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities.

Phase 4

Completed

• Conditions: Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities; Endovascular Repair of Aortic Aneurysm
• Interventions: Drug: Propofol; Drug: Sevoflurane; Drug: Remifentanil

• Registration Number: NCT02107170
• Lead Sponsor: Tao Zhang

Brief Summary

Endovascular repair of aortic aneurysm and endovascular treatment of arteriosclerosis obliterans of lower extremities are two kinds of common surgeries in the investigators' hospital. The effects of anesthetic agents on postoperative outcome, especially cognitive function, are not clear. In this study investigators propose to measure postoperative cognitive function and other outcome of patients who are undergoing these two kinds of surgeries, and try to identify whether there is an association between different kinds of anesthetics and postoperative outcome. Investigators will also observe whether changes in plasma levels of VEGF, TGF-1, TNF-α, IL-1β, and IL-6, are associated with postoperative delirium or cognitive change.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-25
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-08
• Primary Completion: 2017-10
• Study Completion: 2017-12
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-10
• Last Update Posted: 2018-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• age 18-100 years of age
• Patients presenting for Endovascular repair of aortic aneurysm and endovascular treatment of arteriosclerosis obliterans of lower extremities

Exclusion Criteria

• Patients with pre-existing delirium
• Inablility to converse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol & remifentanil	Propofol	propofol (50 - 150 µg/kg/min) plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.
propofol & remifentanil	Remifentanil	propofol (50 - 150 µg/kg/min) plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.
Sevoflurane & remifentanil	Sevoflurane	sevoflurane at 0.5 to 1.5 minimum alveolar concentrations plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.
Sevoflurane & remifentanil	Remifentanil	sevoflurane at 0.5 to 1.5 minimum alveolar concentrations plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.

Primary Outcome Measures

Name	Time	Method
Number of patients with postoperative cognitive dysfunction	7 days after surgery

Secondary Outcome Measures

Name	Time	Method
Number of patients with postoperative cognitive dysfunction	3 months after surgery
Changes in plasma levels of VEGF, TGF-1, TNF-α, IL-1β, and IL-6 (a composite outcome measure)	3 days after surgery

Trial Locations

Locations (1)

First Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China