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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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ClinicalTrials.gov Identifier: NCT02107170
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Tao Zhang, First Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment Phase
Endovascular Repair of Aortic Aneurysm Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities Drug: Sevoflurane Drug: Propofol Drug: Remifentanil Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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.
Actual Study Start Date : February 2014
Actual Primary Completion Date : October 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sevoflurane & remifentanil
sevoflurane at 0.5 to 1.5 minimum alveolar concentrations plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.
Drug: Sevoflurane
sevoflurane-based general anesthesia

Drug: Remifentanil
Active Comparator: propofol & remifentanil
propofol (50 - 150 µg/kg/min) plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.
Drug: Propofol
total intravenous anesthesia

Drug: Remifentanil



Primary Outcome Measures :
  1. Number of patients with postoperative cognitive dysfunction [ Time Frame: 7 days after surgery ]

Secondary Outcome Measures :
  1. Number of patients with postoperative cognitive dysfunction [ Time Frame: 3 months after surgery ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107170


Locations
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China, Guangdong
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Tao Zhang

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Responsible Party: Tao Zhang, Department of anesthesiology, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02107170     History of Changes
Other Study ID Numbers: VIAEV
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Arteriosclerosis
Arteriosclerosis Obliterans
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Arterial Occlusive Diseases
Propofol
Anesthetics
Sevoflurane
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation