Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cognitive Dysfunction
  • Melatonin
  • Postoperative Complications
  • Prostate Hyperplasia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: randomized, parallel assignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: triple maskingPrimary Purpose: Prevention

Participation Requirements

Age
Between 60 years and 125 years
Gender
Only males

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 th...

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,

Tracking Information

NCT #
NCT03966950
Collaborators
Not Provided
Investigators
Principal Investigator: Maria JC Carmona, PHD Associate Professor