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Completed

NCT Number: NCT01905488

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

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.

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Key information

Age range

56 year–78 year

Sex eligibility

Male

Study type

Observational

Primary location

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 23, 2013
Registry last updated
Jul 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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