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

NCT ID: NCT02107170

Last Updated: 2018-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sevoflurane & remifentanil

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

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

sevoflurane-based general anesthesia

Remifentanil

Intervention Type DRUG

propofol & remifentanil

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

total intravenous anesthesia

Remifentanil

Intervention Type DRUG

Interventions

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Sevoflurane

sevoflurane-based general anesthesia

Intervention Type DRUG

Propofol

total intravenous anesthesia

Intervention Type DRUG

Remifentanil

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tao Zhang

OTHER

Sponsor Role lead

Responsible Party

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Tao Zhang

Department of anesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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VIAEV

Identifier Type: -

Identifier Source: org_study_id

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