Back to resultsEffects of Anesthetics on Postoperative Cognitive Function of Patients Undergoing Endovascular Repair of Aortic Aneurysm and Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities.
Primary Purpose
Endovascular Repair of Aortic Aneurysm, Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sevoflurane
Propofol
Remifentanil
Sponsored by
About this trial
This is an interventional prevention trial for Endovascular Repair of Aortic Aneurysm
Eligibility Criteria
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
Sites / Locations
- First Affiliated Hospital, Sun Yat-Sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sevoflurane & remifentanil
propofol & remifentanil
Arm Description
sevoflurane at 0.5 to 1.5 minimum alveolar concentrations plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.
propofol (50 - 150 µg/kg/min) plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.
Outcomes
Primary Outcome Measures
Number of patients with postoperative cognitive dysfunction
Secondary Outcome Measures
Number of patients with postoperative cognitive dysfunction
Changes in plasma levels of VEGF, TGF-1, TNF-α, IL-1β, and IL-6 (a composite outcome measure)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02107170
Brief Title
Effects of Anesthetics on Postoperative Cognitive Function of Patients Undergoing Endovascular Repair of Aortic Aneurysm and Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities.
Official Title
Comparison of Intravenous Anesthetics and Volatile Anesthetics on Postoperative Cognitive Dysfunction of Patients Undergoing Endovascular Repair of Aortic Aneurysm and Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tao Zhang
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endovascular Repair of Aortic Aneurysm, Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sevoflurane & remifentanil
Arm Type
Experimental
Arm Description
sevoflurane at 0.5 to 1.5 minimum alveolar concentrations plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.
Arm Title
propofol & remifentanil
Arm Type
Active Comparator
Arm Description
propofol (50 - 150 µg/kg/min) plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
sevoflurane-based general anesthesia
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
total intravenous anesthesia
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Primary Outcome Measure Information:
Title
Number of patients with postoperative cognitive dysfunction
Time Frame
7 days after surgery
Secondary Outcome Measure Information:
Title
Number of patients with postoperative cognitive dysfunction
Time Frame
3 months after surgery
Title
Changes in plasma levels of VEGF, TGF-1, TNF-α, IL-1β, and IL-6 (a composite outcome measure)
Time Frame
3 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
First Affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effects of Anesthetics on Postoperative Cognitive Function of Patients Undergoing Endovascular Repair of Aortic Aneurysm and Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities.
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