search
Back to results

Comparison of Ketamine Combine Propofol vs Propofol Anesthesia in Schizophrenia Electroconvulsive Therapy

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Propofol
Ketamine
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Electroconvulsive therapy, ketamine

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The clinical diagnosis is consistent with the schizophrenia, and the diagnostic requirements are in accordance with the Structural Diagnostic Interview Scale (SCID for Diagnostic and Statistical Manual of Mental Disorders (DSM-5)) and are recognized by psychiatrists as needing electroconvulsive therapy
  • Vision and hearing that can be operated normally or corrected
  • Subject consent form signed by the patient or agent

Exclusion Criteria:

  • Past or recent diagnosis of neurocognitive impairment
  • Contraindications for electroacupuncture treatment within one month, such as: myocardial infarction, cerebrovascular disease, Increase Intracranial pressure, cerebral hemangioma, untreated fracture, cervical spine injury, pheochromocytoma, heart failure, severe heart valve disease, deep Venous embolism, etc
  • Untreated substances abuse disorder(eg illegal drugs, alcohol)
  • Unspecified mental disorder
  • PattientUnable to cooperate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ketamine + propofol group

    propofol group

    Arm Description

    use ketamine + propofol for ECT induction

    use propofol only for ECT induction

    Outcomes

    Primary Outcome Measures

    The therapeutic effect after completing electroconvulsive treatment course
    Record the change of disease illness, use The Clinical Global Impression - Improvement scale (CGI-I) and Clinical Global Impression - Severity scale (CGI-S) CGI-S(Severity) range 1-7 1: normal 7:extremely severe CGI-I(Improvement) range 1-7 1:very much improved 7: vert much worse

    Secondary Outcome Measures

    Change from baseline in Brief Psychiatric Rating Scale (BPRS)
    Brief Psychiatric Rating Scale range:18-126 Contains the following items: Somatic concern Anxiety Depression Suicidality Guilt Hostility Elated Mood Grandiosity Suspiciousness Hallucinations Unusual thought content Bizarre behaviour Self-neglect Disorientation Conceptual disorganisation Blunted affect Emotional withdrawal Motor retardation Tension Uncooperativeness Excitement Distractibility Motor hyperactivity Mannerisms and posturing Different item scores will have different results and outcomes ""Different values represent is not meaning a better or worse outcome, it must compare to the patient's status before""

    Full Information

    First Posted
    January 13, 2019
    Last Updated
    May 26, 2019
    Sponsor
    Chang Gung Memorial Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03829124
    Brief Title
    Comparison of Ketamine Combine Propofol vs Propofol Anesthesia in Schizophrenia Electroconvulsive Therapy
    Official Title
    Comparison of Propofol Combine Ketamine Anesthesia and Propofol Anesthesia in Schizophrenia Electroconvulsive Therapy: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 24, 2019 (Anticipated)
    Primary Completion Date
    January 19, 2021 (Anticipated)
    Study Completion Date
    April 20, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    Brief Summary
    Electroconvulsive therapy (ECT) serves as an effective adjuvant modality for major depressive disorder, schizophrenia, or bipolar affective disorder refractory to or contraindicated to psychopharmacological treatment. Anesthetics have been introduced into ECT sessions to alleviate ECT-inducing discomfort sensation, tachycardia, arrhythmia, hypertension, and anxiety. Propofol is able to rapidly cross the blood-brain barrier (BBB), which leads to rapid onset of sedation and hypnosis. Meanwhile, propofol has hemodynamic depressant effect and attenuates hypertensive surge during ECT. Characteristics mentioned above make propofol one of widely used anesthetics for anesthetized ECT. However, propofol is also well known for anticonvulsant property. Thus, dosage of electrical stimulus may be increased to achieve ideal seizure quality in this setting, which also leads to higher risk of subsequent cognitive impairment or other complications. Ketamine has also been widely used in the induction of anesthesia for the treatment of major depressive disease in recent years. It has been found to increase the permeability and therapeutic effect of antidepressants. Compared to traditional Barbiturate drugs or propofol, do not increase the threshold of electricity required by electroporation, which can reduce the time required for symptom relief of those drugs, It is a viable alternative induction drug. There have been confirmed that ketamine combine propofol can be used for electroconvulsive treatment in patients with major depression and bipolar disorder, and even better Electroconvulsive quality can be obtained. Reduce the number of Electroconvulsive treatments and reduce the duration of treatment. However, the current literature has not yet verified the clinical benefit of ketamine combine propofol as an anesthetic induction drug in patients with schizophrenia who are receiving electroconvulsive therapy, and it is worthy of further study. In the investigator's clinical practice, the purpose of this experiment is to explore: compared with propofol base anesthesia alone, and the combine use of ketamine and propofol may reduce the threshold of seizure, improve the quality of Electroconvulsive therapy and shorten the course of treatment. The combine use and titrate the drugs helps to reduce the side effects of both ketamine and propofol (such as cardiovascular side effects and positive symptoms) , achieve better Electroconvulsive therapy and effects.
    Detailed Description
    Electroconvulsive therapy (ECT) serves as an effective adjuvant or alternative modality for major depressive disorder, schizophrenia, or bipolar affective disorder refractory to or contraindicated to psychopharmacological treatment. Anesthetics have been introduced into ECT sessions to alleviate ECT-inducing discomfort sensation, tachycardia, arrhythmia, hypertension, and anxiety. Propofol is highly lipid soluble and able to rapidly cross the blood-brain barrier (BBB), which leads to rapid onset of sedation and hypnosis. Meanwhile, propofol has hemodynamic depressant effect and attenuates hypertensive surge during ECT. Characteristics mentioned above make propofol one of widely used anesthetics for anesthetized ECT. However, propofol is also well known for anticonvulsant property, which may inevitably interfere with seizure propagation by electroconvulsive stimulus and diminish consequent efficacy. Thus, dosage of electrical stimulus may be increased to achieve ideal seizure quality in this setting, which also leads to higher risk of subsequent cognitive impairment or other complications. Ketamine has also been widely used in the induction of anesthesia for the treatment of major depressive disease in recent years. It has been found to increase the permeability and therapeutic effect of antidepressants. Compared to traditional Barbiturate drugs or propofol, do not increase the threshold of electricity required by electroporation, which can reduce the time required for symptom relief of those drugs, It is a viable alternative induction drug. However, ketamine causes short-term dissociative symptoms, which may temporarily aggravate the positive symptoms of patients with schizophrenia after Electroconvulsive therapy, but the time of aggravation of positive symptoms generally does not exceed 30 minutes. There have been many studies in the clinic, and it has been confirmed that ketamine combine propofol can be used for electroconvulsive treatment in patients with major depression and bipolar disorder, and even better Electroconvulsive quality can be obtained. Reduce the number of Electroconvulsive treatments and reduce the duration of treatment. However, the current literature has not yet verified the clinical benefit of ketamine combine propofol as an anesthetic induction drug in patients with schizophrenia who are receiving electroconvulsive therapy, and it is worthy of further study. In the investigator's clinical practice, the purpose of this experiment is to explore: compared with propofol base anesthesia alone, and the combine use of ketamine and propofol may reduce the threshold of seizure, improve the quality of Electroconvulsive therapy and shorten the course of treatment. The combine use and titrate the drugs helps to reduce the side effects of both ketamine and propofol (such as cardiovascular side effects and positive symptoms) , achieve better Electroconvulsive therapy and effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia
    Keywords
    Electroconvulsive therapy, ketamine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ketamine + propofol group
    Arm Type
    Experimental
    Arm Description
    use ketamine + propofol for ECT induction
    Arm Title
    propofol group
    Arm Type
    Active Comparator
    Arm Description
    use propofol only for ECT induction
    Intervention Type
    Drug
    Intervention Name(s)
    Propofol
    Intervention Description
    Propofol 10mg/ml IV push slowly 0.5-2mg/kg
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine
    Intervention Description
    Ketamine 50mg/ml IV push slowly 0.5- 1mg/kg
    Primary Outcome Measure Information:
    Title
    The therapeutic effect after completing electroconvulsive treatment course
    Description
    Record the change of disease illness, use The Clinical Global Impression - Improvement scale (CGI-I) and Clinical Global Impression - Severity scale (CGI-S) CGI-S(Severity) range 1-7 1: normal 7:extremely severe CGI-I(Improvement) range 1-7 1:very much improved 7: vert much worse
    Time Frame
    At baseline, after 3rd course treatment(average 1-2 week), after 6th course treatment(average 2-4 week), after completion of treatment course( average 4-6 weeks, up to 8 weeks)
    Secondary Outcome Measure Information:
    Title
    Change from baseline in Brief Psychiatric Rating Scale (BPRS)
    Description
    Brief Psychiatric Rating Scale range:18-126 Contains the following items: Somatic concern Anxiety Depression Suicidality Guilt Hostility Elated Mood Grandiosity Suspiciousness Hallucinations Unusual thought content Bizarre behaviour Self-neglect Disorientation Conceptual disorganisation Blunted affect Emotional withdrawal Motor retardation Tension Uncooperativeness Excitement Distractibility Motor hyperactivity Mannerisms and posturing Different item scores will have different results and outcomes ""Different values represent is not meaning a better or worse outcome, it must compare to the patient's status before""
    Time Frame
    At baseline, after 3rd course treatment(average 1-2 week), after 6th course treatment(average 2-4 week), after completion of treatment course( average 4-6 weeks, up to 8 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The clinical diagnosis is consistent with the schizophrenia, and the diagnostic requirements are in accordance with the Structural Diagnostic Interview Scale (SCID for Diagnostic and Statistical Manual of Mental Disorders (DSM-5)) and are recognized by psychiatrists as needing electroconvulsive therapy Vision and hearing that can be operated normally or corrected Subject consent form signed by the patient or agent Exclusion Criteria: Past or recent diagnosis of neurocognitive impairment Contraindications for electroacupuncture treatment within one month, such as: myocardial infarction, cerebrovascular disease, Increase Intracranial pressure, cerebral hemangioma, untreated fracture, cervical spine injury, pheochromocytoma, heart failure, severe heart valve disease, deep Venous embolism, etc Untreated substances abuse disorder(eg illegal drugs, alcohol) Unspecified mental disorder PattientUnable to cooperate

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparison of Ketamine Combine Propofol vs Propofol Anesthesia in Schizophrenia Electroconvulsive Therapy

    We'll reach out to this number within 24 hrs