An interventional study of melatonin and Placebo oral tablet in Melatonin, Cognitive Dysfunction and Postoperative Complications, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to male participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-29.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Prevention
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
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,
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's planned enrollment of 104 is close to the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
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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.
for the melatonin group, 10 mg of melatonin will be taken per os in the evening before the surgery and in the immediate postoperative night and the first and second postoperative days.
Dietary Supplement: melatonin
For the placebo group, placebo will be administered per os in the evening before the surgery and in the immediate postoperative night and the first and second postoperative days.
Drug: Placebo oral tablet
melatonin 10 mg per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights.
placebo taken per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights
early postoperative cognitive dysfunction
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
Time frame: 30 days
late postoperative cognitive dysfunction
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
Time frame: 180 days
Plan to share: Undecided
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University of Sao Paulo