Chhatrapati Shahuji Maharaj Medical University, U.P. & G.M. & Associated Hospitals
Lucknow, Uttar Pradesh, 226003, India
NCT Number: NCT01526395
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Lucknow, Uttar Pradesh, 226003, India
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months
Time frame: 6 months
Time frame: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
Time frame: 6 months
Time frame: 6 months
Time frame: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
Time frame: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
Time frame: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
Time frame: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
Johns Hopkins University
Other
Decreasing the Use of Unmodified ECT in an Indian Hospital
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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