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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03966950
• Other study ID #: melatonin POCD
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2017
• Est. completion date: November 26, 2021

Study information

• Verified date: May 2019
• Source: University of Sao Paulo
• Contact: Maria JC Carmona, PHD
• Phone: +5511996450293
• Email: maria.carmona[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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,

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: November 26, 2021
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Hyperplasia
• Melatonin
• Postoperative Complications
• Prostate Hyperplasia
• Prostatic Hyperplasia

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (10)

Becher KF. [Delirium in geriatric urology patients]. Urologe A. 2019 Apr;58(4):398-402. doi: 10.1007/s00120-019-0887-4. Review. German. — View Citation

Cardinali DP, Furio AM, Brusco LI. The use of chronobiotics in the resynchronization of the sleep/wake cycle. Therapeutical application in the early phases of Alzheimer's disease. Recent Pat Endocr Metab Immune Drug Discov. 2011 May;5(2):80-90. Review. — View Citation

Fan Y, Yuan L, Ji M, Yang J, Gao D. The effect of melatonin on early postoperative cognitive decline in elderly patients undergoing hip arthroplasty: A randomized controlled trial. J Clin Anesth. 2017 Jun;39:77-81. doi: 10.1016/j.jclinane.2017.03.023. Epu — View Citation

Kotekar N, Kuruvilla CS, Murthy V. Post-operative cognitive dysfunction in the elderly: A prospective clinical study. Indian J Anaesth. 2014 May;58(3):263-8. doi: 10.4103/0019-5049.135034. — View Citation

Kotekar N, Shenkar A, Nagaraj R. Postoperative cognitive dysfunction - current preventive strategies. Clin Interv Aging. 2018 Nov 8;13:2267-2273. doi: 10.2147/CIA.S133896. eCollection 2018. Review. — View Citation

Marra A, McGrane TJ, Henson CP, Pandharipande PP. Melatonin in Critical Care. Crit Care Clin. 2019 Apr;35(2):329-340. doi: 10.1016/j.ccc.2018.11.008. Epub 2019 Jan 30. Review. — View Citation

Rasmussen LS, Johnson T, Kuipers HM, Kristensen D, Siersma VD, Vila P, Jolles J, Papaioannou A, Abildstrom H, Silverstein JH, Bonal JA, Raeder J, Nielsen IK, Korttila K, Munoz L, Dodds C, Hanning CD, Moller JT; ISPOCD2(International Study of Postoperative — View Citation

Segal-Gidan F. Postoperative confusion in older adults. JAAPA. 2017 Apr;30(4):12-16. doi: 10.1097/01.JAA.0000513345.29384.39. — View Citation

Spinedi E, Cardinali DP. Neuroendocrine-Metabolic Dysfunction and Sleep Disturbances in Neurodegenerative Disorders: Focus on Alzheimer ´s Disease and Melatonin. <br>. Neuroendocrinology. 2018 Oct 28. doi: 10.1159/000494889. [Epub ahead of print] — View Citation

Strøm C, Rasmussen LS, Sieber FE. Should general anaesthesia be avoided in the elderly? Anaesthesia. 2014 Jan;69 Suppl 1:35-44. doi: 10.1111/anae.12493. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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