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

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.

Intervention / Treatment

  • Propofol (DRUG)
    Propofol 10mg/ml IV push slowly 0.5-2mg/kg
  • Ketamine (DRUG)
    Ketamine 50mg/ml IV push slowly 0.5- 1mg/kg

Condition or Disease

  • Schizophrenia

Phase

  • Phase 4
  • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 20 Years to 65 Years
    Enrollment: 1 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: May 24, 2019 ESTIMATED
    Primary Completion: Jan 19, 2021 ESTIMATED
    Completion Date: Apr 20, 2021 ESTIMATED
    Study First Posted: Feb 04, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: May 26, 2019

    Sponsors / Collaborators

    Lead sponsor is responsible party
    Responsible Party: N/A

    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.

    Participant Groups

    • use ketamine + propofol for ECT induction

    • use propofol only for ECT induction

    Eligibility Criteria

    Sex: All
    Minimum Age: 20
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • 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 Outcomes
    • 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""

    More Details

    NCT Number: NCT03829124
    Other IDs: 201800056A3
    Study URL: https://clinicaltrials.gov/study/NCT03829124
    Last updated: Sep 29, 2023