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

Primary Purpose

Major Depressive Disorder, Bipolar Disorder, Schizophrenia

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Propofol

About this trial

This is an interventional supportive care trial for Major Depressive Disorder focused on measuring electroconvulsive therapy, ECT, unmodified, anesthesia, propofol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Unmodified ECT

Low Dose Propofol

Arm Description

Data will be collected on patients receiving ECT in its unmodified form prior to the introduction of low dose propofol sedation.

Subjects will be given low dose propofol prior to ECT.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate at which ECT is offered and refused.

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

Inpatient length of stay calculated from onset of ECT administration.

Number of ECTs required to complete a course of treatment

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.

Cognitive changes, monitored by the Mini Mental State Examination (MMSE)

Monitoring of adverse effects such the occurence of emergent delirium, headaches, muscle aches, nausea and vomiting, and fractures and dislocations.

Monitoring of delirium using the test with the Confusion Assessment Method for the ICU (CAM-ICU).

Full Information

NCT ID

NCT01526395

First Posted

December 21, 2011

Last Updated

April 1, 2013

Sponsor

Johns Hopkins University

Collaborators

Johns Hopkins Bloomberg School of Public Health, Chhatrapati Shahuji Maharaj Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01526395

Brief Title

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

Official Title

Decreasing the Use of Unmodified ECT in an Indian Hospital

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Johns Hopkins University

Collaborators

Johns Hopkins Bloomberg School of Public Health, Chhatrapati Shahuji Maharaj Medical University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder, Bipolar Disorder, Schizophrenia

Keywords

electroconvulsive therapy, ECT, unmodified, anesthesia, propofol

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Unmodified ECT

Arm Type

No Intervention

Arm Description

Data will be collected on patients receiving ECT in its unmodified form prior to the introduction of low dose propofol sedation.

Arm Title

Low Dose Propofol

Arm Type

Active Comparator

Arm Description

Subjects will be given low dose propofol prior to ECT.

Intervention Type

Drug

Intervention Name(s)

Propofol

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Rate at which ECT is offered and refused.

Time Frame

6 months

Title

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

Time Frame

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

Title

Inpatient length of stay calculated from onset of ECT administration.

Time Frame

6 months

Title

Number of ECTs required to complete a course of treatment

Time Frame

6 months

Title

Time Frame

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

Title

Cognitive changes, monitored by the Mini Mental State Examination (MMSE)

Time Frame

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

Title

Monitoring of adverse effects such the occurence of emergent delirium, headaches, muscle aches, nausea and vomiting, and fractures and dislocations.

Time Frame

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

Title

Monitoring of delirium using the test with the Confusion Assessment Method for the ICU (CAM-ICU).

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Irving M Reti, MBBS

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Lucknow

State/Province

Uttar Pradesh

ZIP/Postal Code

226003

Country

India

12. IPD Sharing Statement

Learn more about this trial

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

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