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

NCT02107170 | Completed Phase 4

• 1 other identifier: VIAEV
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Endovascular Repair of Aortic Aneurysm; Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities

Outcome Measures

Primary Outcomes (1)

• Number of patients with postoperative cognitive dysfunction

  7 days after surgery

Secondary Outcomes (2)

• 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

Study Arms (2)

Sevoflurane & remifentanil

EXPERIMENTAL

sevoflurane at 0.5 to 1.5 minimum alveolar concentrations plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.

Drug: Sevoflurane; Drug: Remifentanil

propofol & remifentanil

ACTIVE COMPARATOR

propofol (50 - 150 µg/kg/min) plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.

Drug: Propofol; Drug: Remifentanil

Interventions

Sevoflurane DRUG

sevoflurane-based general anesthesia

Sevoflurane & remifentanil

Propofol DRUG

total intravenous anesthesia

propofol & remifentanil

Remifentanil DRUG

Sevoflurane & remifentanil; propofol & remifentanil

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with pre-existing delirium
• Inablility to converse

Sponsors & Collaborators

• Tao Zhang: lead

Study Sites (1)

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Interventions

Sevoflurane; Propofol; Remifentanil

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of anesthesiology

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: April 8, 2014
• Study Start: February 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 12, 2018

Record last verified: 2018-06

Locations

CN (1)