Trial record 6 of 4001 for:    Arteriosclerosis

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. (see Contacts and Locations)
Verified April 2014 by First Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Tao Zhang, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT02107170
First received: March 25, 2014
Last updated: April 4, 2014
Last verified: April 2014
  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 Blind (Subject, 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 First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • Number of patients with postoperative cognitive dysfunction [ Time Frame: 7 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with postoperative cognitive dysfunction [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: February 2014
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 25, 2014
Last Updated: April 4, 2014
Health Authority: National Health and Family Planning Commission: China.

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

ClinicalTrials.gov processed this record on July 29, 2014