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

NCT03966950 | Unknown

• 1 other identifier: melatonin POCD
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Conditions

Melatonin; Cognitive Dysfunction; Postoperative Complications; Prostate Hyperplasia

Keywords

Melatonin; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• late postoperative cognitive dysfunction

  180 days

Study Arms (2)

melatonin group

EXPERIMENTAL

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.

Dietary Supplement: melatonin

placebo group

PLACEBO COMPARATOR

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.

Drug: Placebo oral tablet

Interventions

melatonin DIETARY_SUPPLEMENT

melatonin 10 mg per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights.

melatonin group

Placebo oral tablet DRUG

placebo taken per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights

placebo group

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clinicas

São Paulo, São Paulo, 05403010, Brazil

RECRUITING

Related Publications (11)

• 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.

  PMID: 25024467 RESULT

• 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.

  PMID: 30519008 RESULT

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

  PMID: 28282301 RESULT

• Strom C, Rasmussen LS, Sieber FE. Should general anaesthesia be avoided in the elderly? Anaesthesia. 2014 Jan;69 Suppl 1(Suppl 1):35-44. doi: 10.1111/anae.12493.

  PMID: 24303859 RESULT

• 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 Cognitive Dysfunction) Investigators. Does anaesthesia cause postoperative cognitive dysfunction? A randomised study of regional versus general anaesthesia in 438 elderly patients. Acta Anaesthesiol Scand. 2003 Mar;47(3):260-6. doi: 10.1034/j.1399-6576.2003.00057.x.

  PMID: 12648190 RESULT

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

  PMID: 30859233 RESULT

• 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. Epub 2017 Mar 31.

  PMID: 28494914 RESULT

• 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. doi: 10.2174/187221411799015354.

  PMID: 22074583 RESULT

• Spinedi E, Cardinali DP. Neuroendocrine-Metabolic Dysfunction and Sleep Disturbances in Neurodegenerative Disorders: Focus on Alzheimer's Disease and Melatonin. Neuroendocrinology. 2019;108(4):354-364. doi: 10.1159/000494889. Epub 2018 Oct 28.

  PMID: 30368508 RESULT

• 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.

  PMID: 30784613 RESULT

• Madsen BK, Zetner D, Moller AM, Rosenberg J. Melatonin for preoperative and postoperative anxiety in adults. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD009861. doi: 10.1002/14651858.CD009861.pub3.

  PMID: 33319916 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Postoperative Complications; Prostatic Hyperplasia

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Maria JC Carmona, PHD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria JC Carmona, PHD

CONTACT

+5511996450293; maria.carmona@hc.fm.usp.br

Cristiane Tavares, MD

CONTACT

+5511983039765; cristianetav@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: triple masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: randomized, parallel assignment

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 29, 2019
• Study Start: June 26, 2017
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2021
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

BR (1)