Comparison of Esketamine/Propofol and Methohexital Anesthesia for ECT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methohexital, Ketofol.
- Who it may be relevant to
- Registry conditions: ECT, Depression. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Randomized, Double Blind, Controlled, Safety and Non-inferiority Study of Esketamine Plus Propofol Compared to Methohexital Anesthesia for Electroconvulsive Therapy
Overview
The current anesthetic drug used as standard for ECT procedure at the Department of Psychiatry and Psychotherapy, Medical University of Vienna, is the barbiturate methohexital (Brevital®). As far as we know, methohexital is the most common anesthetic in the procedure of ECT. Only few heterogeneous randomized controlled trials to directly compare the use of (sole) ketamine and methohexital in ECT with relatively small sample sizes have been conducted so far, showing inconclusive findings: a retrospective comparison of methohexital and switch to ketamine anesthesia in 36 patients showed that ketamine prolonged seizure duration and accelerated posttreatment orientation. Others compared both drugs in terms of recovery and reorientation time showing that reorientation time was faster in the methohexital group (total N=9). Another study showed no difference in any outcome measure (depressive symptom improvement, cognition, adverse events) between both groups (total N=16, N=9 per group). Finally, a comparative investigation (total N=37, N=20 vs. N=17) detected no differences between both anesthetics but a higher systolic blood pressure posttreatment and longer motor seizure duration in the ketamine group. A favorable profile of ketamine in regards to seizure quality has been reported, however in terms of outcome measures methohexital and ketamine were similar (total N=50, N=23 vs. N=27). The present study is designed as a prospective randomized non-inferiority trial comparing esketamine plus propofol (ratio 1:1, for better readability from now on referred to as "ketofol") to methohexital, the latter being the current standard anesthetic applied for ECT procedure at our department. Patients eligible for ECT will be randomly assigned to receive anesthesia with either ketofol or methohexital for the whole course of the individual ECT series. Group differences will be investigated both in regards to outcomes related to anesthesia, treatment-outcome and seizure quality. Further, changes in cardiac enzyme levels before and after ECT-treatment and during the entire ECT series will be evaluated and possible group differences will be explored. As stated above the sole/adjunct administration of ketamine as anesthetic agent for ECT has been associated with better seizure quality, similar antidepressant outcomes and anesthesia-associated events, while there is some evidence suggesting that the use of ketamine might present some advantages to other anesthetics in terms of cognitive side-effects accompanying ECT. Therefore, the aim of the present study will be to establish ketofol as a new standard for anesthesia at our Department.
Interventions
- Drug Methohexital
anesthesia during ECT - Drug Ketofol
anesthesia during ECT
Primary outcome measures
- antidepressant effect [Time frame: 4 weeks]
- recovery time [Time frame: 4 weeks]
Secondary outcome measures (5)
- adverse events [Time frame: 4 weeks]
- concomitant medication [Time frame: 4 weeks]
- cognition [Time frame: 4 weeks]
- time to reorientation [Time frame: 4 weeks]
- seizure quality [Time frame: 4 weeks]
Eligibility criteria
Inclusion criteria
- male or female inpatients
- age ≥ 18 years
- ICD-11 diagnosis of severe uni- or bipolar depression (F32.2, F32.2, F33.2, F33.3, F31.4, F31.5)
- Hamilton Depression Rating Scale HAMD17 ≥ 24
- ability to understand and willingness to sign written informed consent document
- negative urine pregnancy test in women
- anesthesiological approval for ECT (Classification of the American Society of Anesthesiologists ASA ≤ 3)
- antidepressant and antipsychotic medication in steady state for at least 7 days prior to first ECT treatment
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Austria · 1 center
- Pia Baldinger-Melich — Vienna
Identifiers
NCT: NCT05655754 · BMF22114