A prospective randomized, double blind, controlled, safety and non-inferiority study of esketamine plus propofol compared to methohexital anesthesia for electroconvulsive therapy - Comparison of ketofol and methohexital anesthesia for ECT

Medical University of Vienna0 个研究点目标入组 100 人开始时间: 2022年6月2日最近更新: 2022年8月8日

适应症

试验速览

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•-male or female inpatients
•-age = 18 years
•-ICD-10 diagnosis of severe uni- or bipolar depression (F32.2, F32.2, F33.2, F33.3, F31.4, F31.5)
•-HAMD17 = 24
•ability to understand and willingness to sign written informed consent document
•-antidepressant and antipsychotic medication in steady state for at least 7 days prior inclusion
•-negative urine pregnancy test in women
•-anesthesiological approval for ECT (ASA = 3)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 85
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•-severe somatic or neurological disease (esp. current or previous history of intracranial hypertension, uncontrolled severe hypertension, bleeds or aneurysm, recent myocardial infarction)
•-current or past history of schizophrenia or schizoaffective disorder
•-clinical relevant abnormalities on a general physical examination and routine laboratory screening
•-pregnancy, breast feeding
•-known allergy to the study drugs or compounds of the latter

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