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

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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)

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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