Perioperative Melatonin in Lumbar Laminectomy
Perioperative Analgesic and Anxiolytic Effect of Melatonin in Patients Undergoing Lumbar Laminectomy
1 other identifier
interventional
84
1 country
1
Brief Summary
Patients undergoing lumbar laminectomy surgery will receive either 5 or 10 mg melatonin or placebo once the evening before surgery and again 90 minutes before surgery. Pain and anxiety will be assessed over the 24 hour period following surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 17, 2010
CompletedFirst Posted
Study publicly available on registry
May 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedMay 19, 2010
April 1, 2010
1.2 years
May 17, 2010
May 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pain
Pain will be assessed over a 24 hour period following surgery using a visual analogue scale
24 hours
Anxiety
Anxiety will be assessed over a 24 hour following surgery using visual analogue scale
24 hours
Study Arms (3)
Melatonin 5 mg
EXPERIMENTALPatients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
Melatonin 10 mg
EXPERIMENTALPatients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
Placebo
PLACEBO COMPARATORPatients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.
Interventions
Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.
Eligibility Criteria
You may qualify if:
- age 18 to 65 years old
- ASA status 1-3
- having lumbar laminectomy 2 to 3 levels with or without fusion
You may not qualify if:
- receiving emergent procedure
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Related Publications (1)
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.
PMID: 33319916DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Peng, MD
University Health Network, Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 17, 2010
First Posted
May 19, 2010
Study Start
April 1, 2010
Primary Completion
July 1, 2011
Study Completion
September 1, 2011
Last Updated
May 19, 2010
Record last verified: 2010-04