The Healthy Heart-Mind Trial: Randomized Controlled Trial of Melatonin for Prevention of Delirium.
cardiothoracic
delirium
melatonin
prevention
surgery
Journal
Journal of the American Geriatrics Society
ISSN: 1532-5415
Titre abrégé: J Am Geriatr Soc
Pays: United States
ID NLM: 7503062
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
received:
01
07
2019
revised:
13
08
2019
accepted:
13
08
2019
pubmed:
9
10
2019
medline:
15
8
2020
entrez:
10
10
2019
Statut:
ppublish
Résumé
Delirium is a serious medical condition with increased incidence in at-risk surgical populations. We sought to determine if melatonin use reduces the incidence of delirium in individuals undergoing major cardiac surgery. Randomized double-blind placebo-controlled clinical trial (two arms, 1:1 allocation, parallel design). The trial took place in two metropolitan hospitals (public tertiary and private) in Perth, Western Australia. We recruited 210 adults aged 50 years or older who were due to undergo coronary artery bypass grafting or valve replacement surgery. Participants were randomly assigned (1:1) to 7 days of treatment with melatonin 3 mg at night or matching placebo, starting 2 days before the surgery. The primary outcome of interest was incident delirium within 7 days of surgery as assessed via daily clinical assessment that included the Confusion Assessment Method. Secondary outcomes of interest included duration and severity of delirium, length of hospital stay, cognitive function, and mood and anxiety symptoms at discharge and 3 months after the surgery. The groups were well balanced for demographic and clinical parameters. Forty-two participants developed delirium, but it was evenly distributed between the groups (melatonin 21/98, 21.4%; placebo 21/104, 20.2%; adjusted odds ratio [OR] = .78; 95% confidence interval [CI] = .35-1.75). The median duration of delirium was 3 (interquartile range [IQR] = 2-4) and 2 (IQR = 1-3) days for people treated with melatonin and placebo, respectively (z = -1.03; P = .304). A similar proportion of participants experienced severe episodes of delirium in each group (melatonin 9/21, 42.9% vs placebo 6/21, 28.6%; χ The findings of this randomized double-blind placebo-controlled trial do not support the prophylactic use of melatonin to prevent delirium after major cardiac surgery. J Am Geriatr Soc 68:112-119, 2019.
Substances chimiques
Melatonin
JL5DK93RCL
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
112-119Informations de copyright
© 2019 The American Geriatrics Society.
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