Decreasing the Use of Unmodified ECT in an Indian Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Percentage of patients receiving ECT who agree to the modified form of treatment after it is offered.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 >
- •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.
- •Patients with a history of epilepsy
研究组 & 干预措施
Low Dose Propofol
Subjects will be given low dose propofol prior to ECT.
干预措施: Propofol (Drug)
结局指标
主要结局
Percentage of patients receiving ECT who agree to the modified form of treatment after it is offered.
时间窗: 6 months
次要结局
- Rate at which ECT is offered and refused.(6 months)
- Change in patient anxiety measured by the state portion of the State-Trait Anxiety Inventory.(Baseline and completion of ECT treatments or up to 6 months, whichever comes first)
- Inpatient length of stay calculated from onset of ECT administration.(6 months)
- Number of ECTs required to complete a course of treatment(6 months)
- 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.(Baseline and completion of ECT treatments or up to 6 months, whichever comes first)
- Cognitive changes, monitored by the Mini Mental State Examination (MMSE)(Baseline and completion of ECT treatments or up to 6 months, whichever comes first)
- Monitoring of adverse effects such the occurence of emergent delirium, headaches, muscle aches, nausea and vomiting, and fractures and dislocations.(Baseline and completion of ECT treatments or up to 6 months, whichever comes first)
- Monitoring of delirium using the test with the Confusion Assessment Method for the ICU (CAM-ICU).(Baseline and completion of ECT treatments or up to 6 months, whichever comes first)
研究者
Irving Reti
Associate Professor
Johns Hopkins University