Status:
COMPLETED
Study of Melatonin on Sleep, Pain, and Confusion After Joint Replacement Surgery
Lead Sponsor:
Hospital for Special Surgery, New York
Conditions:
Postoperative Pain
Delirium
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Pain, confusion, and breaks in normal sleep cycles have been challenges commonly faced by patients after undergoing joint surgeries. To address these issues, melatonin, an inexpensive over-the-counter...
Detailed Description
Sleep disruption is a challenge commonly faced by patients and care providers in the perioperative period \[1,2\] and has been shown to affect postoperative performance after total knee arthroplasty \...
Eligibility Criteria
Inclusion
- Patients 18-90 years old undergoing elective, primary total knee replacement
- American Society of Anesthesiologists (ASA) Physical Status I-III
- Epidural anesthesia/Patient Controlled Analgesia candidate
Exclusion
- Mental impairment
- Pre-operative use of benzodiazepines, narcotics, or prescription/over-the counter (OTC) sleep aids
- Pre-operative use of calcium channel blockers
- Insomnia
- Recent drug or alcohol abuse
- Psychiatric disorders other than anxiety, including depression
- Diabetes
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01505465
Start Date
February 1 2012
End Date
June 1 2013
Last Update
May 11 2022
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021