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

Prostate Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01905488
• Other study ID #: 4-2009-0056
• Status: Completed
• Phase: N/A
• First received: July 16, 2013
• Last updated: July 18, 2013
• Start date: May 2009
• Est. completion date: November 2009

Study information

• Verified date: July 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 56 Years to 78 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

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. — View Citation

Dresser LP, McKinney WM. Anatomic and pathophysiologic studies of the human internal jugular valve. Am J Surg. 1987 Aug;154(2):220-4. — View 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. — View 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. Epub 2005 Jul 7. — View Citation

Sander D, Winbeck K, Etgen T, Knapp R, Klingelhöfer J, Conrad B. Disturbance of venous flow patterns in patients with transient global amnesia. Lancet. 2000 Dec 9;356(9246):1982-4. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of neurocognitive function from baseline at 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.	2 days after surgery	No