Melatonin for Prevention of Post- Operative Delirium Pilot Study Protocol
To test the efficacy of melatonin compared to placebo in preventing post-operative delirium and reduction in intensity or duration of delirium in individuals 65 years of age and older who undergo orthopedic surgery after low energy lower extremity fractures (LELEF).
Biomarkers may play important roles in the detection, prediction and management of delirium especially in frail elderly individuals. Predictive biomarkers may help characterize an individual's susceptibility to delirium and thereby help specialized treatment, care and management of such individuals during their hospitalization. They may also help predict treatment response to a specific modality and help in selection of such modality. Recent studies performed in the UK and published in 2011 have measured plasma cholinesterase activity and determined that these levels were lower in patients who developed delirium compared with remaining subjects. Other studies have indicated that CRP may also have a role in delirium prediction as they have found that CRP measured on admission to an ICU had predictable changes that occurred within 24 hours that in turn were predictors of delirium. One the aims of the study is to compare the predictive and treatment response values of groups of biomarkers that have been hypothesized to be of predictive value.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Surgery causes oxidative stress on the brain9 leading to inflammation. Post-operative delirium has been linked with inflammation in the brain. Delirium has been hypothesized to be a central nervous system response to systemic inflammation during a state of blood-brain barrier (BBB) compromise.
Studies have shown a rise of inflammatory cytokines and fall of anti-inflammatory cytokines. Vice-versa, external cytokine administration has been shown to lead to delirium. Melatonin is known for its strong anti-oxidant and anti-inflammatory properties, this should account for its preventive properties in post-operative delirium. It has also been hypothesized that post-operative delirium in elderly is caused by circadian rhythm disturbances secondary to a relative lack of melatonin.
Keeping in mind the above two possible pathophysiology for delirium, investigators are expecting melatonin supplementation should be able to reduce the incidence of post-operative delirium particularly in elderly population.
Type d'étude
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Illinois
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Maywood, Illinois, États-Unis, 60153
- Loyola University Medical Center
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients 65 years of age and older undergoing Low Energy Lower Extremity Fractures (LELEF) surgery
- Presence of an LELEF fracture
- Low Energy (e.g., falls from standing height, falls from sitting, etc.).
Operative Fractures:
- Pathologic femur and tibia fractures
- Femoral neck fractures
- Pertroch: including intertroch, subtroch fractures
- Femoral shaft
- Supracondylar femur fractures
- Periprosthetic fractures around total hip and total knee arthroplasties
- Tibial plateau fractures
- Proximal Tibia Fractures
- Tibial Shaft Fractures
- Distal 1/3 tibia fractures
- Ankle Fractures that are admitted
Exclusion Criteria:
- Patients with previous adverse reaction or side-effects to melatonin
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
- Inability to communicate in English
- Patients with a Montreal Cognitive Assessment (MoCA) score of below 7 will not be included in the study because of their inability to give informed consent at that stage. This score is approximately 2 standard deviation below average score for Alzheimer's Dementia.
- Participants who are unable to give consent or communicate well in English will not be enrolled
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Placebo
Individuals who are randomized to the control arm will receive liquid placebo sublingually 60-90 minutes prior to surgery.
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10 mg liquid placebo at 7 pm for 1 week
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Comparateur actif: Melatonin
Individuals who are randomized to the treatment arm will receive 10 mg liquid IR-SL melatonin 60-90 minutes prior to surgery
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10 mg liquid Melatonin IR-SL at 7 pm for 1 week
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Delirium assessment
Délai: 1 Week
|
The Delirium Rating Scale Revised (DRS-R98) will be given to all patients every day for seven days.
Investigators will compare the scores recorded on day 7 between those receiving melatonin versus those receiving placebo controlling for their baseline performance.
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1 Week
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hospital stay
Délai: 1 Week
|
Length of hospital stay will be recorded for all patients and compared between the two treatment groups (i.e., those receiving melatonin and those receiving placebo).
|
1 Week
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Muralidhara S Rao, MD, Loyola University
Publications et liens utiles
Publications générales
- Deiner S, Silverstein JH. Postoperative delirium and cognitive dysfunction. Br J Anaesth. 2009 Dec;103 Suppl 1(Suppl 1):i41-46. doi: 10.1093/bja/aep291.
- Bekker AY, Weeks EJ. Cognitive function after anaesthesia in the elderly. Best Pract Res Clin Anaesthesiol. 2003 Jun;17(2):259-72. doi: 10.1016/s1521-6896(03)00005-3.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Maladies du système nerveux
- Manifestations neurologiques
- Confusion
- Manifestations neurocomportementales
- Troubles neurocognitifs
- Délire
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Dépresseurs du système nerveux central
- Agents protecteurs
- Antioxydants
- Mélatonine
Autres numéros d'identification d'étude
- 206981
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