Decreasing the Use of Unmodified Electroconvulsive Therapy (ECT) in an Indian Hospital

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: Chhatrapati Shahuji Maharaj Medical University; Johns Hopkins Bloomberg School of Public Health
• Treatments: Propofol

Criteria

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