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

Johns Hopkins University

Status: Completed

Conditions: Major Depressive Disorder; Schizophrenia; Bipolar Disorder

Treatments: Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01526395

NA_00027421

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 99 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

Unmodified ECT

No Intervention group

Description:

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 group

Description:

Subjects will be given low dose propofol prior to ECT.

Treatment:

Drug: Propofol