Decreasing the Use of Unmodified Electroconvulsive Therapy (ECT) in an Indian Hospital - Full Text View

Purpose

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.

Condition	Intervention
Major Depressive Disorder Bipolar Disorder Schizophrenia	Drug: Propofol

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Decreasing the Use of Unmodified ECT in an Indian Hospital

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Bipolar Disorder Depression Nausea and Vomiting Schizophrenia

Drug Information available for: Propofol

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Percentage of patients receiving ECT who agree to the modified form of treatment after it is offered. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate at which ECT is offered and refused. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Inpatient length of stay calculated from onset of ECT administration. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Number of ECTs required to complete a course of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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. [ Time Frame: Baseline and completion of ECT treatments or up to 6 months, whichever comes first ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Enrollment:	99
Study Start Date:	August 2011
Study Completion Date:	April 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Unmodified ECT Data will be collected on patients receiving ECT in its unmodified form prior to the introduction of low dose propofol sedation.
Active Comparator: Low Dose Propofol Subjects will be given low dose propofol prior to ECT.	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. Other Name: Propofol

Arms

Assigned Interventions

No Intervention: Unmodified ECT

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

Active Comparator: Low Dose Propofol

Subjects will be given low dose propofol prior to ECT.

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.

Other Name: Propofol

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526395

Locations

India
Chhatrapati Shahuji Maharaj Medical University, U.P. & G.M. & Associated Hospitals
Lucknow, Uttar Pradesh, India, 226003

Sponsors and Collaborators

Johns Hopkins University

Johns Hopkins Bloomberg School of Public Health

Chhatrapati Shahuji Maharaj Medical University

Investigators

Principal Investigator:

Irving M Reti, MBBS

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Irving Reti, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT01526395 History of Changes
Other Study ID Numbers:	NA_00027421
Study First Received:	December 21, 2011
Last Updated:	April 1, 2013
Health Authority:	United States: Institutional Review Board India: Institutional Review Board

Keywords provided by Johns Hopkins University:

electroconvulsive therapy
ECT
unmodified
anesthesia
propofol

Additional relevant MeSH terms:

Bipolar Disorder
Depressive Disorder
Depression
Schizophrenia
Depressive Disorder, Major
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features

Propofol
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 19, 2013