Status:
COMPLETED
Decreasing the Use of Unmodified Electroconvulsive Therapy (ECT) in an Indian Hospital
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Johns Hopkins Bloomberg School of Public Health
Chhatrapati Shahuji Maharaj Medical University
Conditions:
Major Depressive Disorder
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 decr...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT01526395
Start Date
August 1 2011
End Date
April 1 2012
Last Update
April 4 2013
Active Locations (1)
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1
Chhatrapati Shahuji Maharaj Medical University, U.P. & G.M. & Associated Hospitals
Lucknow, Uttar Pradesh, India, 226003