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MelatoninNCT03966950

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

A study testing melatonin in people with Melatonin and Cognitive Dysfunction, run by University of Sao Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 60 years and older, men onlyHealthy volunteers can take part
What is being tested?
melatonin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
104 participants
Where
1 siteBrazil
Study dates
26 Jun 2017to 26 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Maria JC Carmona, PHD contact

+5511996450293

maria.carmona@hc.fm.usp.br

Cristiane Tavares, MD contact

+5511983039765

cristianetav@gmail.com

Brazil1 site, 1 recruiting

  • Hospital das Clinicas

    São Paulo, São Paulo, 05403010

    Maria JC Carmona, PhD, +5511986613950, maria.carmona@incor.usp.br

    Cristiane Tavares, MD, +5511983039765, cristianetav@gmail.com

    Recruiting

Other trials in Brazil

About this study

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

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

Read the 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,

Being tested
melatonin, Placebo oral tablet
Keywords
Melatonin, Cognitive Dysfunction
Medical subject headings
Cognitive Dysfunction, Postoperative Complications, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • melatoninDietary supplement

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

  • Placebo oral tabletDrug

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

Study groups in NCT03966950
Study groupRoleWhat they receive
melatonin groupExperimentalfor 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.
Receives: Dietary Supplement: melatonin
placebo groupPlacebo comparatorFor 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.
Receives: Drug: Placebo oral tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 30 days

Secondary outcomes (1)

  1. 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

    Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2019
  2. Study start26 Jun 2017
  3. Primary completion26 Nov 2019 (estimated)
  4. Study completion26 Nov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized, parallel assignment
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03966950
Sponsor's protocol ID
melatonin POCD
Status last verified
May 2019
First submitted
14 May 2019
Last updated
29 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25024467

  • 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.

    PubMed 30519008

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

    PubMed 28282301

  • 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.

    PubMed 24303859

  • 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.

    PubMed 12648190

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

    PubMed 30859233

  • 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.

    PubMed 28494914

  • 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.

    PubMed 22074583

  • 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.

    PubMed 30368508

  • 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.

    PubMed 30784613

  • 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.

    PubMed 33319916

Questions about this trial

What is this clinical trial studying?

A study testing melatonin in people with Melatonin and Cognitive Dysfunction, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Maria JC Carmona, PHD (+5511996450293, maria.carmona@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

early postoperative cognitive dysfunction (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03966950, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.

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