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

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ClinicalTrials.gov Identifier: NCT03829124
Recruitment Status : Unknown
Verified January 2019 by Chang Gung Memorial Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Tracking Information
First Submitted Date  ICMJE January 13, 2019
First Posted Date  ICMJE February 4, 2019
Last Update Posted Date May 29, 2019
Estimated Study Start Date  ICMJE May 24, 2019
Estimated Primary Completion Date January 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
The therapeutic effect after completing electroconvulsive treatment course [ 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) ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
The therapeutic effect after completing electroconvulsive treatment course [ Time Frame: After completion of treatment course( average 4 weeks) ]
Record the improvement of disease illness (use The Clinical Global Impression - Improvement scale (CGI-I))
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
Change from baseline in Brief Psychiatric Rating Scale (BPRS) [ 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) ]
Brief Psychiatric Rating Scale range:18-126 Contains the following items:
  1. Somatic concern
  2. Anxiety
  3. Depression
  4. Suicidality
  5. Guilt
  6. Hostility
  7. Elated Mood
  8. Grandiosity
  9. Suspiciousness
  10. Hallucinations
  11. Unusual thought content
  12. Bizarre behaviour
  13. Self-neglect
  14. Disorientation
  15. Conceptual disorganisation
  16. Blunted affect
  17. Emotional withdrawal
  18. Motor retardation
  19. Tension
  20. Uncooperativeness
  21. Excitement
  22. Distractibility
  23. Motor hyperactivity
  24. 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""
Original Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
  • Monitor therapeutic responses after the 3rd treatment [ Time Frame: After the 3rd treatment ( average 1 week) ]
    Record the presence and severity of disease illness(use The Clinical Global Impression - Severity scale (CGI-S)
  • Monitor therapeutic responses after the 6th treatment [ Time Frame: After the 6th treatment ( average 2 week) ]
    Record the presence and severity of disease illness(use The Clinical Global Impression - Severity scale (CGI-S)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Ketamine Combine Propofol vs Propofol Anesthesia in Schizophrenia Electroconvulsive Therapy
Official Title  ICMJE Comparison of Propofol Combine Ketamine Anesthesia and Propofol Anesthesia in Schizophrenia Electroconvulsive Therapy: A Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Propofol
    Propofol 10mg/ml IV push slowly 0.5-2mg/kg
  • Drug: Ketamine
    Ketamine 50mg/ml IV push slowly 0.5- 1mg/kg
Study Arms  ICMJE
  • Experimental: ketamine + propofol group
    use ketamine + propofol for ECT induction
    Interventions:
    • Drug: Propofol
    • Drug: Ketamine
  • Active Comparator: propofol group
    use propofol only for ECT induction
    Intervention: Drug: Propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 1, 2019)
1
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 20, 2021
Estimated Primary Completion Date January 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03829124
Other Study ID Numbers  ICMJE 201800056A3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chang Gung Memorial Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP