Study of Melatonin on Sleep, Pain, and Confusion After Joint Replacement Surgery

NCT01505465 | Completed Results

• 1 other identifier: 2012-032
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 supplement, has shown in previous to help manage sleep disorders, prevent and treat post-operative confusion in patients over 70 years of age, and reduce pain. The purpose of this study is to establish whether melatonin can aid in reducing pain and post-operative confusion and improve sleep quality after total knee replacement

Conditions

Postoperative Pain; Delirium; Confusion; Sleep

Keywords

Total Knee Replacement; Pain; Confusion; Sleep

Outcome Measures

Primary Outcomes (1)

• Perioperative Sleep Efficiency

  Sleep time change from 96 hours before surgery to 72 hours after surgery

  96 hours before surgery to 72 hours after surgery

Secondary Outcomes (4)

• Perioperative Effects of Melatonin on Post-operative Pain Scores

  Up to postoperative day 3

• Melatonin Effects on Delirium During Post-operative Inpatient Stay Based on Clinical Assessment in Patients 65 and Older

  Up to postoperative day 3

• Melatonin Effects on Daytime Activity

  Up to postoperative day 3

• Melatonin Effects on Patient Controlled Analgesia and Postoperative Narcotic Usage

  Up to 3 days

Study Arms (2)

Study: Melatonin

EXPERIMENTAL

Drug: Melatonin

Control: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Melatonin DRUG

5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.

Study: Melatonin

Placebo DRUG

5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery

Control: Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (16)

• Ozler M, Simsek K, Ozkan C, Akgul EO, Topal T, Oter S, Korkmaz A. Comparison of the effect of topical and systemic melatonin administration on delayed wound healing in rats that underwent pinealectomy. Scand J Clin Lab Invest. 2010 Oct;70(6):447-52. doi: 10.3109/00365513.2010.506926.

  PMID: 20704520 BACKGROUND

• Gitto E, Romeo C, Reiter RJ, Impellizzeri P, Pesce S, Basile M, Antonuccio P, Trimarchi G, Gentile C, Barberi I, Zuccarello B. Melatonin reduces oxidative stress in surgical neonates. J Pediatr Surg. 2004 Feb;39(2):184-9; discussion 184-9. doi: 10.1016/j.jpedsurg.2003.10.003.

  PMID: 14966737 BACKGROUND

• Gitto E, Karbownik M, Reiter RJ, Tan DX, Cuzzocrea S, Chiurazzi P, Cordaro S, Corona G, Trimarchi G, Barberi I. Effects of melatonin treatment in septic newborns. Pediatr Res. 2001 Dec;50(6):756-60. doi: 10.1203/00006450-200112000-00021.

  PMID: 11726736 BACKGROUND

• Gitto E, Reiter RJ, Cordaro SP, La Rosa M, Chiurazzi P, Trimarchi G, Gitto P, Calabro MP, Barberi I. Oxidative and inflammatory parameters in respiratory distress syndrome of preterm newborns: beneficial effects of melatonin. Am J Perinatol. 2004 May;21(4):209-16. doi: 10.1055/s-2004-828610.

  PMID: 15168319 BACKGROUND

• Kucukakin B, Wilhelmsen M, Lykkesfeldt J, Reiter RJ, Rosenberg J, Gogenur I. No effect of melatonin to modify surgical-stress response after major vascular surgery: a randomised placebo-controlled trial. Eur J Vasc Endovasc Surg. 2010 Oct;40(4):461-7. doi: 10.1016/j.ejvs.2010.06.014. Epub 2010 Jul 17.

  PMID: 20638874 BACKGROUND

• Kucukakin B, Klein M, Lykkesfeldt J, Reiter RJ, Rosenberg J, Gogenur I. No effect of melatonin on oxidative stress after laparoscopic cholecystectomy: a randomized placebo-controlled trial. Acta Anaesthesiol Scand. 2010 Oct;54(9):1121-7. doi: 10.1111/j.1399-6576.2010.02294.x.

  PMID: 20887414 BACKGROUND

• Shigeta H, Yasui A, Nimura Y, Machida N, Kageyama M, Miura M, Menjo M, Ikeda K. Postoperative delirium and melatonin levels in elderly patients. Am J Surg. 2001 Nov;182(5):449-54. doi: 10.1016/s0002-9610(01)00761-9.

  PMID: 11754849 BACKGROUND

• Yin YQ, Luo AL, Guo XY, Li LH, Huang YG. Postoperative neuropsychological change and its underlying mechanism in patients undergoing coronary artery bypass grafting. Chin Med J (Engl). 2007 Nov 20;120(22):1951-7.

  PMID: 18067777 BACKGROUND

• Karkela J, Vakkuri O, Kaukinen S, Huang WQ, Pasanen M. The influence of anaesthesia and surgery on the circadian rhythm of melatonin. Acta Anaesthesiol Scand. 2002 Jan;46(1):30-6. doi: 10.1034/j.1399-6576.2002.460106.x.

  PMID: 11903069 BACKGROUND

• Caumo W, Torres F, Moreira NL Jr, Auzani JA, Monteiro CA, Londero G, Ribeiro DF, Hidalgo MP. The clinical impact of preoperative melatonin on postoperative outcomes in patients undergoing abdominal hysterectomy. Anesth Analg. 2007 Nov;105(5):1263-71, table of contents. doi: 10.1213/01.ane.0000282834.78456.90.

  PMID: 17959953 BACKGROUND

• Caumo W, Levandovski R, Hidalgo MP. Preoperative anxiolytic effect of melatonin and clonidine on postoperative pain and morphine consumption in patients undergoing abdominal hysterectomy: a double-blind, randomized, placebo-controlled study. J Pain. 2009 Jan;10(1):100-8. doi: 10.1016/j.jpain.2008.08.007. Epub 2008 Nov 17.

  PMID: 19010741 BACKGROUND

• Wilhelmsen M, Amirian I, Reiter RJ, Rosenberg J, Gogenur I. Analgesic effects of melatonin: a review of current evidence from experimental and clinical studies. J Pineal Res. 2011 Oct;51(3):270-7. doi: 10.1111/j.1600-079X.2011.00895.x. Epub 2011 May 26.

  PMID: 21615490 BACKGROUND

• Papp M, Litwa E, Gruca P, Mocaer E. Anxiolytic-like activity of agomelatine and melatonin in three animal models of anxiety. Behav Pharmacol. 2006 Feb;17(1):9-18. doi: 10.1097/01.fbp.0000181601.72535.9d.

  PMID: 16377959 BACKGROUND

• Yousaf F, Seet E, Venkatraghavan L, Abrishami A, Chung F. Efficacy and safety of melatonin as an anxiolytic and analgesic in the perioperative period: a qualitative systematic review of randomized trials. Anesthesiology. 2010 Oct;113(4):968-76. doi: 10.1097/ALN.0b013e3181e7d626.

  PMID: 20823763 BACKGROUND

• Al-Aama T, Brymer C, Gutmanis I, Woolmore-Goodwin SM, Esbaugh J, Dasgupta M. Melatonin decreases delirium in elderly patients: a randomized, placebo-controlled trial. Int J Geriatr Psychiatry. 2011 Jul;26(7):687-94. doi: 10.1002/gps.2582. Epub 2010 Sep 15.

  PMID: 20845391 BACKGROUND

• Sultan SS. Assessment of role of perioperative melatonin in prevention and treatment of postoperative delirium after hip arthroplasty under spinal anesthesia in the elderly. Saudi J Anaesth. 2010 Sep;4(3):169-73. doi: 10.4103/1658-354X.71132.

  PMID: 21189854 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Delirium; Confusion; Pain

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Memtsoudis
• Organization: HSS

MemtsoudisS@hss.edu

(212) 606-1000

Study Officials

• Stavros G. Memtsoudis, MD, PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: January 6, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 11, 2022
• Results First Posted: August 31, 2017

Record last verified: 2022-04

Locations

US (1)