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

NCT01526395 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2013-04-04

No results posted yet for this study

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

Interventions

DRUG

Propofol

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.

Sponsors & Collaborators

  • Johns Hopkins Bloomberg School of Public Health

    collaborator OTHER

  • Chhatrapati Shahuji Maharaj Medical University

    collaborator OTHER

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Irving M Reti, MBBS · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01526395 on ClinicalTrials.gov