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

Not Applicable

• Conditions: Postoperative Complications; Melatonin; Cognitive Dysfunction; Prostate Hyperplasia
• Interventions: Dietary Supplement: melatonin; Drug: Placebo oral tablet

• Registration Number: NCT03966950
• Lead Sponsor: University of Sao Paulo

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,

Study Timeline

• Study Start: 2017-06-26
• Status Verified: 2019-05
• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-28
• Last Update Submitted: 2019-05-28
• Study First Posted: 2019-05-29
• Last Update Posted: 2019-05-29
• Primary Completion: 2019-11-26
• Study Completion: 2021-11-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
melatonin group	melatonin	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.
placebo group	Placebo oral tablet	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital das Clinicas; 🇧🇷 São Paulo, SP, Brazil