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
84 participants
INTERVENTIONAL
2010-04-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Melatonin 5 mg
Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
5 mg melatonin
Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
Melatonin 10 mg
Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
10 mg melatonin
Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
Placebo
Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.
Placebo
Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.
Interventions
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5 mg melatonin
Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
10 mg melatonin
Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
Placebo
Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.
Eligibility Criteria
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Inclusion Criteria
* ASA status 1-3
* having lumbar laminectomy 2 to 3 levels with or without fusion
Exclusion Criteria
* surgery for neoplastic spine lesion
* allergy to melatonin or its non-medicinal ingredients
* allergy or contraindication
* BMI over 35 or or less than 20 kg/m2
* pregnancy or breastfeeding
* failure to provide informed consent
18 Years
65 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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University Health Network
Principal Investigators
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Philip Peng, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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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09-0172-B
Identifier Type: -
Identifier Source: org_study_id
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