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

University of Sao Paulo

Status: Unknown

Conditions: Postoperative Complications; Prostate Hyperplasia; Cognitive Dysfunction; Melatonin

Treatments: Drug: Placebo oral tablet; Dietary Supplement: melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT03966950

melatonin POCD

Details and patient eligibility

About

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

Full 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,

Enrollment: 104 estimated patients

Sex: Male

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups, including a placebo group

melatonin group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: melatonin

placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo oral tablet