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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.

This study is currently recruiting participants.
Verified April 2017 by Tao Zhang, First Affiliated Hospital, Sun Yat-Sen University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02107170
First Posted: April 8, 2014
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Tao Zhang, First Affiliated Hospital, Sun Yat-Sen University
  Purpose
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 Intervention Phase
Endovascular Repair of Aortic Aneurysm Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities Drug: Sevoflurane Drug: Propofol Drug: Remifentanil Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Tao Zhang, First Affiliated Hospital, Sun Yat-Sen University:

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

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

Estimated Enrollment: 400
Study Start Date: February 2014
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Tao Zhang, Master of Medicine 13580482938 zhtao98@aliyun.com

Locations
China, Guangdong
First Affiliated Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Tao Zhang, Master of Medicine    13580482938    zhtao98@aliyun.com   
Sponsors and Collaborators
Tao Zhang
  More Information

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 Submitted: March 25, 2014
First Posted: April 8, 2014
Last Update Posted: April 25, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Arteriosclerosis
Arteriosclerosis Obliterans
Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Arterial Occlusive Diseases
Propofol
Remifentanil
Anesthetics
Sevoflurane
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