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.
調査の概要
詳細な説明
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.
研究の種類
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Illinois
-
Maywood、Illinois、アメリカ、60153
- Loyola University Medical Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Placebo
Individuals who are randomized to the control arm will receive liquid placebo sublingually 60-90 minutes prior to surgery.
|
10 mg liquid placebo at 7 pm for 1 week
|
|
アクティブコンパレータ：Melatonin
Individuals who are randomized to the treatment arm will receive 10 mg liquid IR-SL melatonin 60-90 minutes prior to surgery
|
10 mg liquid Melatonin IR-SL at 7 pm for 1 week
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Delirium assessment
時間枠：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.
|
1 Week
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hospital stay
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Muralidhara S Rao, MD、Loyola University
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。