Use of Melatonin for Preventing POCD in Transurethral Prostate Resection Under Spinal Anesthesia
NCT ID: NCT03966950
Last Updated: 2019-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
104 participants
INTERVENTIONAL
2017-06-26
2021-11-26
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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melatonin group
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.
melatonin
melatonin 10 mg per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights.
placebo group
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.
Placebo oral tablet
placebo taken per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights
Interventions
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melatonin
melatonin 10 mg per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights.
Placebo oral tablet
placebo taken per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights
Eligibility Criteria
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Inclusion Criteria
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
Lack of proficiency in portuguese mild or severe hearing loss or blindness.
60 Years
MALE
Yes
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Maria José Carvalho Carmona
professor
Principal Investigators
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Maria JC Carmona, PHD
Role: PRINCIPAL_INVESTIGATOR
Associate Professor
Locations
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Hospital das Clinicas
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Segal-Gidan F. Postoperative confusion in older adults. JAAPA. 2017 Apr;30(4):12-16. doi: 10.1097/01.JAA.0000513345.29384.39.
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.
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.
Becher KF. [Delirium in geriatric urology patients]. Urologe A. 2019 Apr;58(4):398-402. doi: 10.1007/s00120-019-0887-4. German.
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.
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.
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.
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.
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.
Other Identifiers
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melatonin POCD
Identifier Type: -
Identifier Source: org_study_id
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