NCT05655754 Comparison of Esketamine/Propofol and Methohexital Anesthesia for ECT
| NCT ID | NCT05655754 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Medical University of Vienna |
| Condition | ECT |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2022-11-01 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Frequently Asked Questions
Who can join the NCT05655754 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ECT. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05655754 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05655754 currently recruiting?
Yes, NCT05655754 is actively recruiting participants. Visit ClinicalTrials.gov or contact Medical University of Vienna to inquire about joining.
Where is the NCT05655754 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT05655754 clinical trial?
NCT05655754 is sponsored by Medical University of Vienna. The trial plans to enroll 100 participants.