Clinical trial NCT01905488: Perioperative Changes of Cognitive Function According to Jugular Vein Insufficiency in Robot-assisted Prostatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 50
Sex: MALE
Minimum age (years): 56
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Change of neurocognitive function from baseline at 2 days after surgery
timeFrame: 2 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
citation: Akkawi NM, Agosti C, Borroni B, Rozzini L, Magoni M, Vignolo LA, Padovani A. Jugular valve incompetence: a study using air contrast ultrasonography on a general population. J Ultrasound Med. 2002 Jul;21(7):747-51. doi: 10.7863/jum.2002.21.7.747.
citation: Silva MA, Deen KI, Fernando DJ, Sheriffdeen AH. The internal jugular vein valve may have a significant role in the prevention of venous reflux: evidence from live and cadaveric human subjects. Clin Physiol Funct Imaging. 2002 May;22(3):202-5. doi: 10.1046/j.1475-097x.2002.00418.x.
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citation: Nedelmann M, Eicke BM, Dieterich M. Increased incidence of jugular valve insufficiency in patients with transient global amnesia. J Neurol. 2005 Dec;252(12):1482-6. doi: 10.1007/s00415-005-0894-9. Epub 2005 Jul 7.
citation: Maalikjy Akkawi N, Agosti C, Anzola GP, Borroni B, Magoni M, Pezzini A, Rozzini L, Vignolo LA, Padovani A. Transient global amnesia: a clinical and sonographic study. Eur Neurol. 2003;49(2):67-71. doi: 10.1159/000068501.