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

Schizophrenia Clinical Trial

Official title:

Comparison of Propofol Combine Ketamine Anesthesia and Propofol Anesthesia in Schizophrenia Electroconvulsive Therapy: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03829124
• Other study ID #: 201800056A3
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 24, 2019
• Est. completion date: April 20, 2021

Study information

• Verified date: January 2019
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1
• Est. completion date: April 20, 2021
• Est. primary completion date: January 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Propofol
Propofol 10mg/ml IV push slowly 0.5-2mg/kg
• Ketamine
Ketamine 50mg/ml IV push slowly 0.5- 1mg/kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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""	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)