Decreasing the Use of Unmodified Electroconvulsive Therapy (ECT) in an Indian Hospital
2013年4月1日 更新者：Irving Reti、Johns Hopkins University
Decreasing the Use of Unmodified ECT in an Indian Hospital
In developing countries, electroconvulsive therapy (ECT) is typically delivered without the use of an anesthetic prior to the treatment, known as unmodified ECT.
This interventional study aims to decrease the practice of unmodified ECT at Chhatrapati Shahuji Maharaj Medical University, U.P. & G.M. & Associated Hospitals (C.S.M) by administering a low dose anesthetic (propofol) prior to ECT delivery.
In so doing, the investigators hope to facilitate the transition from unmodified to modified ECT without incurring excessive costs to the center.
It is hypothesized that ECT patients will opt for modified treatment, that adverse effects will be minimal, and that costs will not rise prohibitively.
調査の概要
詳細な説明
Patients that are currently receiving unmodified ECT at C.S.M Hospital will be eligible for the first phase of the study in which only data is collected.
Three months after study start, patients who are to receive ECT for a psychiatric disorder will be eligible to participate in the intervention (introduction of propofol at a low dose prior to ECT).
Data collection will include information such as demographics, ratings scales, seizure length, anxiety level, adverse events, and number of treatments.
研究の種類
介入
入学 (実際)
99
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Uttar Pradesh
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Lucknow、Uttar Pradesh、インド、226003
- Chhatrapati Shahuji Maharaj Medical University, U.P. & G.M. & Associated Hospitals
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Subjects are any psychiatric patients at C.S.M. for whom ECT is recommended by their doctor, whether or not they actually receive ECT.
- Subjects must also have an American Society for Anesthesiologists (ASA) rating score of 1 (completely healthy) or 2 (mild systemic disease) with stable symptoms and laboratory values.
- Subjects must be between the ages of 18 to 65 years old and be able to give informed consent.
Exclusion Criteria:
- Patients who speak neither English nor Hindi.
- History of or anatomical evidence for a difficult airway being a short mandible, micrognathia, large tongue or large goiter, arthritis of the jaw or neck, or enlarged tonsils. For this reason we will also exclude patients with a BMI > 28.
- Respiratory tract disease including asthma, respiratory infection, chest wall disease, chronic obstructive pulmonary disease, obstructive sleep apnea, or other disorder which might compromise the airway. Patients who smoke 15 or more cigarettes per day will be excluded unless abstinent for at least 10 days, to reduce the risk of respiratory complications.
- Patients who receive modified ECT during the first phase of the study.
- Pregnant women or women who are breastfeeding.
- Hypersensitivity to propofol or any of its components.
- Patients who are hemodynamically unstable or who have impaired cardiac function.
- BMI < 18.
- Patients with a history of epilepsy
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：支持療法
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Unmodified ECT
Data will be collected on patients receiving ECT in its unmodified form prior to the introduction of low dose propofol sedation.
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アクティブコンパレータ：Low Dose Propofol
Subjects will be given low dose propofol prior to ECT.
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The major intervention proposed in this study is the introduction of low dose IV propofol for sedation prior to ECT treatment at C.S.M Medical University.
The investigators will use a dose of 0.25 to 0.50 mg/kg of IV propofol.
The maximum dose of 0.50 mg/kg is not sufficient for anesthesia (i.e., to make unconscious), but should provide a light level of sedation and be "amnestic," meaning the patient should have memory loss for the period of time around the ECT procedure itself.
The propofol dose will be titrated upwards (from an initial dose of 0.25 mg/kg) with successive treatments in increments of 0.05mg/kg, until it is just sufficient to be lightly sedating.
ECT will be administered 30 to 60 seconds after propofol is injected.
ECT may be given up to three times per week.
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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 |
時間枠 |
|---|---|
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Percentage of patients receiving ECT who agree to the modified form of treatment after it is offered.
時間枠：6 months
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6 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Rate at which ECT is offered and refused.
時間枠：6 months
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6 months
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Change in patient anxiety measured by the state portion of the State-Trait Anxiety Inventory.
時間枠：Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Inpatient length of stay calculated from onset of ECT administration.
時間枠：6 months
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6 months
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Number of ECTs required to complete a course of treatment
時間枠：6 months
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6 months
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Changes in scales used to assess severity of symptoms. The investigators will record changes in the Hamilton Depression Rating Scale, the Young Mania Rating Scale, the Brief Psychiatric Rating Scale and the Clinical Global Impression Severity scale.
時間枠：Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Cognitive changes, monitored by the Mini Mental State Examination (MMSE)
時間枠：Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Monitoring of adverse effects such the occurence of emergent delirium, headaches, muscle aches, nausea and vomiting, and fractures and dislocations.
時間枠：Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Monitoring of delirium using the test with the Confusion Assessment Method for the ICU (CAM-ICU).
時間枠：Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Irving M Reti, MBBS、Johns Hopkins University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年8月1日
一次修了 (実際)
2012年4月1日
研究の完了 (実際)
2012年4月1日
試験登録日
最初に提出
2011年12月21日
QC基準を満たした最初の提出物
2012年2月1日
最初の投稿 (見積もり)
2012年2月3日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年4月4日
QC基準を満たした最後の更新が送信されました
2013年4月1日
最終確認日
2013年4月1日
詳しくは
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