Postoperative Cognitive Dysfunction Clinical Trial
Official title:
Correlation of Preoperative Anxiety With Early Postoperative Cognitive Dysfunction in Breast Cancer Patients
Breast cancer is the most common type of cancer in women. Anxiety and depression often accompany the treatment phase of oncology patients. Since both anxiety and depression are associated with increased inflammatory activity, these preoperative symptoms may predispose patients to the development of postoperative neurocognitive dysfunction. The aim of this study is to reveal the correlation of preoperative anxiety with early postoperative cognitive dysfunction in patients with breast cancer who will undergo surgery.
Status | Completed |
Enrollment | 200 |
Est. completion date | July 13, 2021 |
Est. primary completion date | May 31, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Should be female 2. Should be between 18-65 years old 3. Diagnosed with breast cancer 4. Scoring 21 or above in the MoCA test, 5. Patients under general anesthesia 6. Are decided to have Total Mastectomy, Modified Radical Mastectomy or Breast Conserving surgery 7. Having a risk score of The American society of Anesthesiologists (ASA) risk score 3 and below Exclusion Criteria: 1. Cerebral ischemia or hemorrhage history 2. Clinical diagnosis of Neurodegenerative disease 3. Clinical diagnosis of carotid stenosis, 4. The score 20 or less in the Moca test, 5. Carotid endarterectomy history 6. Aneurysm surgery history 7. Alcohol addiction 8. Clinical diagnosis of psychiatric disease 9. Cervical surgery history 10. Inability to comply with the questionnaire or study 11. Chemotherapy history |
Country | Name | City | State |
---|---|---|---|
Turkey | Dr.Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital clinic of Anesthesiology and Reanimation | Ankara |
Lead Sponsor | Collaborator |
---|---|
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital |
Turkey,
Alam A, Hana Z, Jin Z, Suen KC, Ma D. Surgery, neuroinflammation and cognitive impairment. EBioMedicine. 2018 Nov;37:547-556. doi: 10.1016/j.ebiom.2018.10.021. Epub 2018 Oct 19. Review. — View Citation
Camacho A. Is anxious-depression an inflammatory state? Med Hypotheses. 2013 Oct;81(4):577-81. doi: 10.1016/j.mehy.2013.07.006. Epub 2013 Jul 26. — View Citation
Carlson LE, Angen M, Cullum J, Goodey E, Koopmans J, Lamont L, MacRae JH, Martin M, Pelletier G, Robinson J, Simpson JS, Speca M, Tillotson L, Bultz BD. High levels of untreated distress and fatigue in cancer patients. Br J Cancer. 2004 Jun 14;90(12):2297-304. — View Citation
Linden W, Vodermaier A, Mackenzie R, Greig D. Anxiety and depression after cancer diagnosis: prevalence rates by cancer type, gender, and age. J Affect Disord. 2012 Dec 10;141(2-3):343-51. doi: 10.1016/j.jad.2012.03.025. Epub 2012 Jun 21. — View Citation
Peng L, Xu L, Ouyang W. Role of peripheral inflammatory markers in postoperative cognitive dysfunction (POCD): a meta-analysis. PLoS One. 2013 Nov 13;8(11):e79624. doi: 10.1371/journal.pone.0079624. eCollection 2013. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determining the preoperative anxiety level and evaluating the difference between the preoperative moca test and the moca test performed on the postoperative 7th day (early period) | The researcher will perform the neurocognitive level with a face-to-face interview with the moca test before surgery. In the postoperative period, the test will be repeated on the 7th day.
If the moca test is above 21, it will be considered normal. and the patient will be enrolled. A decrease of 4 units in the moca test on the 7th postoperative day will be considered as postoperative cognitive dysfunction. |
7th postoperative day |
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