Back to resultsUse of Melatonin for Preventing POCD in Transurethral Prostate Resection Under Spinal Anesthesia
Primary Purpose
Melatonin, Cognitive Dysfunction, Postoperative Complications
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
melatonin
Placebo oral tablet
Sponsored by
About this trial
This is an interventional prevention trial for Melatonin focused on measuring Melatonin, Cognitive Dysfunction
Eligibility 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.
Sites / Locations
- Hospital das ClinicasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
melatonin group
placebo group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03966950
Brief Title
Use of Melatonin for Preventing POCD in Transurethral Prostate Resection Under Spinal Anesthesia
Official Title
Use of Melatonin for Prevention of POCD After TURP Surgery Under Spinal Anesthesia for Elderly Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 26, 2017 (Actual)
Primary Completion Date
November 26, 2019 (Anticipated)
Study Completion Date
November 26, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melatonin, Cognitive Dysfunction, Postoperative Complications, Prostate Hyperplasia
Keywords
Melatonin, Cognitive Dysfunction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, parallel assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
triple masking
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
melatonin group
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
melatonin
Intervention Description
melatonin 10 mg per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights.
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
placebo taken per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights
Primary Outcome Measure Information:
Title
early postoperative cognitive dysfunction
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
late postoperative cognitive dysfunction
Description
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
Time Frame
180 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria JC Carmona, PHD
Phone
+5511996450293
Email
maria.carmona@hc.fm.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Cristiane Tavares, MD
Phone
+5511983039765
Email
cristianetav@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria JC Carmona, PHD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria JC Carmona, PhD
Phone
+5511986613950
Email
maria.carmona@incor.usp.br
First Name & Middle Initial & Last Name & Degree
Cristiane Tavares, MD
Phone
+5511983039765
Email
cristianetav@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25024467
Citation
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.
Results Reference
result
PubMed Identifier
30519008
Citation
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.
Results Reference
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PubMed Identifier
28282301
Citation
Segal-Gidan F. Postoperative confusion in older adults. JAAPA. 2017 Apr;30(4):12-16. doi: 10.1097/01.JAA.0000513345.29384.39.
Results Reference
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PubMed Identifier
24303859
Citation
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.
Results Reference
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PubMed Identifier
12648190
Citation
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PubMed Identifier
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Citation
Becher KF. [Delirium in geriatric urology patients]. Urologe A. 2019 Apr;58(4):398-402. doi: 10.1007/s00120-019-0887-4. German.
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PubMed Identifier
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Citation
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.
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PubMed Identifier
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Citation
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Citation
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Results Reference
derived
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Use of Melatonin for Preventing POCD in Transurethral Prostate Resection Under Spinal Anesthesia
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