Use of Melatonin for Preventing POCD in Transurethral Prostate Resection Under Spinal Anesthesia

Study Overview
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Brief Summary
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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
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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,

Official Title
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Use of Melatonin for Prevention of POCD After TURP Surgery Under Spinal Anesthesia for Elderly Patients

Conditions
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Melatonin, Cognitive Dysfunction, Postoperative Complications, Prostate Hyperplasia

Intervention / Treatment
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* Dietary Supplement: melatonin
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, parallel assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: melatonin group<br>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<br>* melatonin 10 mg per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights.<br>|
| Placebo Comparator: placebo group<br>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<br>* placebo taken per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melatonin, Cognitive Dysfunction