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

NCT01526395 | Completed

• 1 other identifier: NA_00027421
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Major Depressive Disorder; Bipolar Disorder; Schizophrenia

Keywords

electroconvulsive therapy; ECT; unmodified; anesthesia; propofol

Outcome Measures

Primary Outcomes (1)

• Percentage of patients receiving ECT who agree to the modified form of treatment after it is offered.

  6 months

Secondary Outcomes (8)

• Rate at which ECT is offered and refused.

  6 months

• Change in patient anxiety measured by the state portion of the State-Trait Anxiety Inventory.

  Baseline and completion of ECT treatments or up to 6 months, whichever comes first

• Inpatient length of stay calculated from onset of ECT administration.

  6 months

• Number of ECTs required to complete a course of treatment

  6 months

• Changes in scales used to assess severity of symptoms. The investigators will record changes in the Hamilton Depression Rating Scale, the Young Mania Rating Scale, the Brief Psychiatric Rating Scale and the Clinical Global Impression Severity scale.

  Baseline and completion of ECT treatments or up to 6 months, whichever comes first

Study Arms (2)

Unmodified ECT

NO INTERVENTION

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

Subjects will be given low dose propofol prior to ECT.

Drug: Propofol

Interventions

Propofol DRUG

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.

Low Dose Propofol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Johns Hopkins Bloomberg School of Public Health: collaborator
• Chhatrapati Shahuji Maharaj Medical University: collaborator

Study Sites (1)

Chhatrapati Shahuji Maharaj Medical University, U.P. & G.M. & Associated Hospitals

Lucknow, Uttar Pradesh, 226003, India

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Schizophrenia

Interventions

Propofol

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Irving M Reti, MBBS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: February 3, 2012
• Study Start: August 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

IN (1)