Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Perioperative Changes of Cognitive Function According to Jugular Vein Insufficiency in Robot-assisted Prostatectomy

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01905488
Recruitment Status : Completed
First Posted : July 23, 2013
Last Update Posted : July 23, 2013
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Internal jugular vein (IJV) is the main pathway of cerebral venous drainage and it has valve system to prevent retrograde blood flow to the brain. Anatomical studies revealed that bicuspid or tricuspid valves were located in both jugular veins 2 cm above the subclavia-jugulars bifurcation and 7-18% of the valves were incompetent. IJVV incompetence (IJVVI) may result in retrograde flow which leads to brain congestion and increase of intracranial pressure, which can cause brain dysfunctions in some patients. IJVVI has been reported to be associated with transient global amnesia (TGA), cough syncope, exertional headache, transient ischemic attack, and air embolism. Demographic data are associated with the development of IJVVI. Akkawi et al. demonstrated that old age over 50 years and male gender are the risk factors for IJVVI. A few physiologic conditions are related with IJVVI including elevated intra-thoracic and intra-abdominal pressure, and pulmonary hypertension. Robot assisted laparoscopic prostatectomy (RLP) is one of the most common robotic surgery because of its significant benefits such as smaller incision, less severe postoperative pain, less intraoperative bleeding, and shorter hospital stay compared to traditional radical prostatectomy. The patients undergoing RLP are mostly over 60 years old, have neurologic, cardiac and pulmonary comorbidities. For RLP, patients are in Trendelenburg position most of the time during surgery, which could cause increases in intra-abdominal and intrathoracic pressure.

Condition or disease
Prostate Cancer

Layout table for study information
Study Type : Observational
Actual Enrollment : 50 participants
Time Perspective: Prospective
Study Start Date : May 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Group/Cohort
Group N
patients who didn't show internal jugula vein valve incompetency (IJVVI)
Group PT
patients who showed IJVVI after pneumoperitoneum or Trendelenburg position
Group S
patients who showed IJVVI in supine position



Primary Outcome Measures :
  1. Change of neurocognitive function from baseline at 2 days after surgery [ Time Frame: 2 days after surgery ]
    Six neurocognitive function tests( 1. Mini-Mental State Examination 2. Auditory Verbal Learning Test 3. Digit Symbol Substitution Test 4. Color Word Stroop Test 5. Digit Span Test 6. Grooved Pegboard Test ) were performed 1 day before surgery as a baseline, then 2 days after surgery as primary outcome parameters. The values between 2 observations were compared to evaluated th neurocognitive dysfunction between groups separated by the presence of IJVVI.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   56 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who were over 50 years old with ASA class I or II, scheduled for robot-assisted laparoscopic prostatectomy
Criteria

Inclusion Criteria:

  • over 50 years old
  • ASA class I or II
  • Scheduled for robot assisted laparoscopic prostatectomy

Exclusion Criteria:

  • previous neurologic deficit
  • history of psychiatric disease, alcoholism or other drug dependency
  • Serious hearing or visual impairment or any other comorbidities which would preclude neuropsychological tests

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): NCT01905488


Locations
Layout table for location information
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Publications:
Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01905488    
Other Study ID Numbers: 4-2009-0056
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: July 23, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases