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.
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
- Conditions the study is for
- Melatonin, Cognitive Dysfunction, Postoperative Complications
- 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.
Brazil1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted29 May 2019
- Study start26 Jun 2017
- Primary completion26 Nov 2019 (estimated)
- Study completion26 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for MelatoninStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria José Carvalho Carmona, University of Sao Paulo
- Investigators
- Maria JC Carmona, PHD, Principal investigator, Associate Professor
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 25024467Kotekar 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 30519008Segal-Gidan F. Postoperative confusion in older adults. JAAPA. 2017 Apr;30(4):12-16. doi: 10.1097/01.JAA.0000513345.29384.39.
PubMed 28282301Strom 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 24303859Rasmussen 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 12648190Becher KF. [Delirium in geriatric urology patients]. Urologe A. 2019 Apr;58(4):398-402. doi: 10.1007/s00120-019-0887-4. German.
PubMed 30859233Fan 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 28494914Cardinali 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 22074583Spinedi 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 30368508Marra 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 30784613Madsen 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
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Melatonin for Prevention of POCD After TURP Surgery Under Spinal Anesthesia for Elderly Patients
- ClinicalTrials.gov ID
- NCT03966950
- Acronym / sponsor ID
- melatonin POCD
- Keywords
- Melatonin, Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 26 Nov 2019 (estimated)
- Study completion
- 26 Nov 2021 (estimated)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, parallel assignment
| Arm | Type | Receives |
|---|---|---|
| melatonin group | Experimental | Dietary Supplement: melatoninfor 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. |
| placebo group | Placebo comparator | Drug: Placebo oral tabletFor 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melatoninmelatonin 10 mg per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights. | Dietary supplement | melatonin group |
| Placebo oral tabletplacebo taken per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights | Drug | placebo group |
Primary outcome
early postoperative cognitive dysfunction
Time frame: 30 days
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
1 secondary outcome
late postoperative cognitive dysfunction
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Results publication: PubMed 25024467Kotekar 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.
- Results publication: PubMed 30519008Kotekar 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.
- Results publication: PubMed 28282301Segal-Gidan F. Postoperative confusion in older adults. JAAPA. 2017 Apr;30(4):12-16. doi: 10.1097/01.JAA.0000513345.29384.39.
- Results publication: PubMed 24303859Strom 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.
- Results publication: PubMed 12648190Rasmussen 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.
- Results publication: PubMed 30859233Becher KF. [Delirium in geriatric urology patients]. Urologe A. 2019 Apr;58(4):398-402. doi: 10.1007/s00120-019-0887-4. German.
- Results publication: PubMed 28494914Fan 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.
- Results publication: PubMed 22074583Cardinali 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.
- Results publication: PubMed 30368508Spinedi 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.
- Results publication: PubMed 30784613Marra 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.
- Derived from this study: PubMed 33319916Madsen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria JC Carmona, PHD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 7 Nov 2026.