Perioperative Melatonin in Lumbar Laminectomy

May 18, 2010 updated by: University Health Network, Toronto

Perioperative Analgesic and Anxiolytic Effect of Melatonin in Patients Undergoing Lumbar Laminectomy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Toronto Western Hospital
        • Contact:
        • Principal Investigator:
          • Philip Peng, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18 to 65 years old
  • ASA status 1-3
  • having lumbar laminectomy 2 to 3 levels with or without fusion

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melatonin 5 mg
Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
Dietary supplement: 5 mg melatonin
Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
Experimental: Melatonin 10 mg
Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
Dietary supplement: 10 mg melatonin
Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
Placebo Comparator: Placebo
Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.
Dietary supplement: Placebo
Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 24 hours
Pain will be assessed over a 24 hour period following surgery using a visual analogue scale
24 hours
Anxiety
Time Frame: 24 hours
Anxiety will be assessed over a 24 hour following surgery using visual analogue scale
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Philip Peng, MD, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

July 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

May 18, 2010

First Posted (Estimate)

May 19, 2010

Study Record Updates

Last Update Posted (Estimate)

May 19, 2010

Last Update Submitted That Met QC Criteria

May 18, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0172-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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