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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05655754
Other study ID # BMF22114
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 1, 2022
Est. completion date October 31, 2025

Study information

Verified date March 2024
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 31, 2025
Est. primary completion date October 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Methohexital
anesthesia during ECT
Ketofol
anesthesia during ECT

Locations

Country Name City State
Austria Pia Baldinger-Melich Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary antidepressant effect • HAMD17 change between baseline and post-ECT in both treatment arms over a series of 8 ECT sessions 4 weeks
Primary recovery time Mean recovery time over 8 ECT sessions in both treatment arms 4 weeks
Secondary adverse events AEs during anesthesia/ECT 4 weeks
Secondary concomitant medication use of concom. medication during intervention to treat AEs 4 weeks
Secondary cognition MMSE, Beck's Depression Inventory (BDI), multiple-choice word test (MWT-B), trail making test (TMT), reaction test (RT), cognitrone (COG), non-verbal learning test (NVLT), verbal learning test (VLT) (Vienna testing system, https://vts.schuhfried.com), compare cognitive outcomes before and after ECT in both treatment arms 4 weeks
Secondary time to reorientation compare time to reorientation in both treatment arms 4 weeks
Secondary seizure quality compare a function of seizure duration, concordance (seizure duration in the electromyogram/seizure duration in the electroencephalogram), midictal amplitude, peak heart rates and interhemispheric coherence in both treatment arms 4 weeks
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