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| Name | Class |
|---|---|
| Johns Hopkins Bloomberg School of Public Health | OTHER |
| Chhatrapati Shahuji Maharaj Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unmodified ECT | No Intervention | Data will be collected on patients receiving ECT in its unmodified form prior to the introduction of low dose propofol sedation. | |
| Low Dose Propofol | Active Comparator | Subjects will be given low dose propofol prior to ECT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients receiving ECT who agree to the modified form of treatment after it is offered. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irving M Reti, MBBS | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chhatrapati Shahuji Maharaj Medical University, U.P. & G.M. & Associated Hospitals | Lucknow | Uttar Pradesh | 226003 | India |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D001714 | Bipolar Disorder |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| 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 |
| D019967 |
| Schizophrenia Spectrum and Other Psychotic Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |