Decreasing the Use of Unmodified Electroconvulsive Therapy (ECT) in an Indian Hospital
1. april 2013 opdateret af: Irving Reti, Johns Hopkins University
Decreasing the Use of Unmodified ECT in an Indian Hospital
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
99
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Uttar Pradesh
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Lucknow, Uttar Pradesh, Indien, 226003
- Chhatrapati Shahuji Maharaj Medical University, U.P. & G.M. & Associated Hospitals
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Unmodified ECT
Data will be collected on patients receiving ECT in its unmodified form prior to the introduction of low dose propofol sedation.
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Aktiv komparator: Low Dose Propofol
Subjects will be given low dose propofol prior to ECT.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Percentage of patients receiving ECT who agree to the modified form of treatment after it is offered.
Tidsramme: 6 months
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6 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Rate at which ECT is offered and refused.
Tidsramme: 6 months
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6 months
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Change in patient anxiety measured by the state portion of the State-Trait Anxiety Inventory.
Tidsramme: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Inpatient length of stay calculated from onset of ECT administration.
Tidsramme: 6 months
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6 months
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Number of ECTs required to complete a course of treatment
Tidsramme: 6 months
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6 months
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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.
Tidsramme: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Cognitive changes, monitored by the Mini Mental State Examination (MMSE)
Tidsramme: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Monitoring of adverse effects such the occurence of emergent delirium, headaches, muscle aches, nausea and vomiting, and fractures and dislocations.
Tidsramme: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Monitoring of delirium using the test with the Confusion Assessment Method for the ICU (CAM-ICU).
Tidsramme: Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Baseline and completion of ECT treatments or up to 6 months, whichever comes first
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Irving M Reti, MBBS, Johns Hopkins University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2011
Primær færdiggørelse (Faktiske)
1. april 2012
Studieafslutning (Faktiske)
1. april 2012
Datoer for studieregistrering
Først indsendt
21. december 2011
Først indsendt, der opfyldte QC-kriterier
1. februar 2012
Først opslået (Skøn)
3. februar 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. april 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. april 2013
Sidst verificeret
1. april 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Patologiske processer
- Stemningsforstyrrelser
- Skizofrenispektrum og andre psykotiske lidelser
- Bipolære og relaterede lidelser
- Depressiv lidelse
- Skizofreni
- Sygdom
- Maniodepressiv
- Depressiv lidelse, major
- Lægemidlers fysiologiske virkninger
- Depressive midler til centralnervesystemet
- Bedøvelsesmidler, intravenøst
- Bedøvelsesmidler, general
- Bedøvelsesmidler
- Hypnotika og beroligende midler
- Propofol
Andre undersøgelses-id-numre
- NA_00027421
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