Trials / Unknown
UnknownNCT03966950
Use of Melatonin for Preventing POCD in Transurethral Prostate Resection Under Spinal Anesthesia
Use of Melatonin for Prevention of POCD After TURP Surgery Under Spinal Anesthesia for Elderly Patients
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- Sponsor
- University of Sao Paulo · Academic / Other
- Sex
- Male
- Age
- 60 Years
- Healthy volunteers
- Accepted
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,
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | melatonin | melatonin 10 mg per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights. |
| DRUG | Placebo oral tablet | placebo taken per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights |
Timeline
- Start date
- 2017-06-26
- Primary completion
- 2019-11-26
- Completion
- 2021-11-26
- First posted
- 2019-05-29
- Last updated
- 2019-05-29
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT03966950. Inclusion in this directory is not an endorsement.