Cognitive Dysfunction, Melatonin, Postoperative Complications, Prostate Hyperplasia
Conditions
Keywords
Melatonin, Cognitive Dysfunction
Brief summary
This study aims to evaluate the possible effect of melatonin on prevention of cognitive dysfunction in the postoperative period of elderly patients undergoing transurethral resection of the prostate (TURP) under spinal anesthesia
Detailed description
TURP is the most common surgical procedure performed on male patients over 60 years of age to treat benign prostatic hyperplasia. One of the concerns, since it compromises the quality of life, is postoperative cognitive dysfunction. It can be due to TURP Syndrome or to other causes, like changing the routine and circadian rhythm for patients with more susceptibility. The investigators postulate that melatonin premedication and use during the perioperative period could avoid cognitive impairment in patients undergoing TURP surgery that didn't develop major complications, like TURP Syndrome. Since anesthestic technic could also influence the outcome of POCD, only patients undergoing spinal anesthesia were included in the study,
Interventions
DIETARY_SUPPLEMENTmelatonin
melatonin 10 mg per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights.
DRUGPlacebo oral tablet
placebo taken per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
triple masking
Intervention model description
randomized, parallel assignment
Eligibility
Sex/Gender
MALE
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
patients over 60 years who underwent elective surgery for transurethral prostate ressection under spinal anesthesia. MME \> 18 (for those who had less than 4 years of formal education ) or MME \> 23 (for those with 4 or more years of formal education)
Exclusion criteria
MME \< 18 (for those who had less than 4 years of formal eduaction) or 23 (for those with 4 years or more of formal eduacation); History of cancer, brain disease, seizure, Parkinson, dementia, hallucination or any disorder that affects cognition before the surgery. Lack of proficiency in portuguese mild or severe hearing loss or blindness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| early postoperative cognitive dysfunction | 30 days | a full battery of neuropsychological tests including FOME (Fuld Object memory evaluation test), Stroops colours world test, Trail making test and Wais-III were applied in the preoperative day and compared to the 30-postoperative day evaluation. A z score decline higher than 0,5 in two different domains defines an early postoperative cognitive dysfunction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| late postoperative cognitive dysfunction | 180 days | neuropsychological testings (WAIS - III, Trail Making Test, Stroop Colours Word Test and Fuld Object Memory Evaluation Test) were applied after 6 months of the surgery and the z score is compared to the preoperative evaluation- a z score decline higher than 0,5 in two different domains can define a late postoperative cognitive dysfunction |
Countries
Brazil
Contacts
Primary ContactMaria JC Carmona, PHD
Backup ContactCristiane Tavares, MD
Outcome results
None listed