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

NCT ID: NCT01905488

Last Updated: 2013-07-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2009-11-30

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.

Conditions

Prostate Cancer

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Group N

patients who didn't show internal jugula vein valve incompetency (IJVVI)

No interventions assigned to this group

Group PT

patients who showed IJVVI after pneumoperitoneum or Trendelenburg position

No interventions assigned to this group

Group S

patients who showed IJVVI in supine position

No interventions assigned to this group

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

• Minimum Eligible Age: 56 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 12099562 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12076346 (View on PubMed)

Dresser LP, McKinney WM. Anatomic and pathophysiologic studies of the human internal jugular valve. Am J Surg. 1987 Aug;154(2):220-4. doi: 10.1016/0002-9610(87)90185-1.

Reference Type: BACKGROUND

PMID: 3631396 (View on PubMed)

Sander D, Winbeck K, Etgen T, Knapp R, Klingelhofer J, Conrad B. Disturbance of venous flow patterns in patients with transient global amnesia. Lancet. 2000 Dec 9;356(9246):1982-4. doi: 10.1016/S0140-6736(00)03313-4.

Reference Type: BACKGROUND

PMID: 11130530 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15999232 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12584412 (View on PubMed)

Other Identifiers

4-2009-0056

Identifier Type: -

Identifier Source: org_study_id