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出境医 / 临床实验 / Use of Melatonin for Preventing POCD in Transurethral Prostate Resection Under Spinal Anesthesia

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

Study Description
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

Condition or disease Intervention/treatment Phase
Melatonin Cognitive Dysfunction Postoperative Complications Prostate Hyperplasia Dietary Supplement: melatonin Drug: Placebo oral tablet Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: triple masking
Primary Purpose: Prevention
Official Title: Use of Melatonin for Prevention of POCD After TURP Surgery Under Spinal Anesthesia for Elderly Patients
Actual Study Start Date : June 26, 2017
Estimated Primary Completion Date : November 26, 2019
Estimated Study Completion Date : November 26, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: 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.
 Dietary Supplement: melatonin
melatonin 10 mg per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights.
Placebo Comparator: 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.
 Drug: Placebo oral tablet
placebo taken per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights
Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. late postoperative cognitive dysfunction [ Time Frame: 180 days ]
    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


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations

Contacts
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Contact: Maria JC Carmona, PHD +5511996450293 maria.carmona@hc.fm.usp.br
Contact: Cristiane Tavares, MD +5511983039765 cristianetav@gmail.com

Locations
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Brazil
Hospital das Clinicas Recruiting
São Paulo, SP, Brazil, 05403010
Contact: Maria JC Carmona, PhD    +5511986613950    maria.carmona@incor.usp.br   
Contact: Cristiane Tavares, MD    +5511983039765    cristianetav@gmail.com   
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Maria JC Carmona, PHD Associate Professor
Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE June 26, 2017
Estimated Primary Completion Date November 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019) 		late postoperative cognitive dysfunction [ Time Frame: 180 days ]
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Melatonin for Preventing POCD in Transurethral Prostate Resection Under Spinal Anesthesia
Official Title  ICMJE Use of Melatonin for Prevention of POCD After TURP Surgery Under Spinal Anesthesia for Elderly Patients
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized, parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
triple masking
Primary Purpose: Prevention
Condition  ICMJE
  • Melatonin
  • Cognitive Dysfunction
  • Postoperative Complications
  • Prostate Hyperplasia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Dietary Supplement: melatonin
  • Placebo Comparator: 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.
    Intervention: Drug: Placebo oral tablet
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.
  • 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.
  • Segal-Gidan F. Postoperative confusion in older adults. JAAPA. 2017 Apr;30(4):12-16. doi: 10.1097/01.JAA.0000513345.29384.39.
  • 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.
  • 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.
  • Becher KF. [Delirium in geriatric urology patients]. Urologe A. 2019 Apr;58(4):398-402. doi: 10.1007/s00120-019-0887-4. Review. 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. Review.
  • 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. Review.
  • 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.
  • Madsen BK, Zetner D, Møller AM, Rosenberg J. Melatonin for preoperative and postoperative anxiety in adults. Cochrane Database Syst Rev. 2020 Dec 8;12:CD009861. doi: 10.1002/14651858.CD009861.pub3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2019) 		104
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 26, 2021
Estimated Primary Completion Date November 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Maria JC Carmona, PHD +5511996450293 maria.carmona@hc.fm.usp.br
Contact: Cristiane Tavares, MD +5511983039765 cristianetav@gmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03966950
Other Study ID Numbers  ICMJE melatonin POCD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Maria José Carvalho Carmona, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maria JC Carmona, PHD Associate Professor
PRS Account University of Sao Paulo
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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