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
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Electroconvulsive therapy, ketamine
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
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
NCT ID
NCT03829124
First Posted
January 13, 2019
Last Updated
May 26, 2019
Sponsor
Chang Gung Memorial Hospital
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
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Comparison of Ketamine Combine Propofol vs Propofol Anesthesia in Schizophrenia Electroconvulsive Therapy
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