Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05655754

Comparison of Esketamine/Propofol and Methohexital Anesthesia for ECT

Led by Medical University of Vienna · Updated on 2025-05-08

100

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Comparison of Esketamine/Propofol and Methohexital Anesthesia for ECT

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female inpatients
  • Age 18 years or older
  • ICD-11 diagnosis of severe unipolar or bipolar depression (F32.2, F32.2, F33.2, F33.3, F31.4, F31.5)
  • Hamilton Depression Rating Scale HAMD17 score of 24 or higher
  • Ability to understand and willingness to sign written informed consent
  • Negative urine pregnancy test for women
  • Anesthesiological approval for ECT with ASA classification of 3 or less
  • Antidepressant and antipsychotic medication in steady state for at least 7 days prior to first ECT treatment
Not Eligible

You will not qualify if you...

  • Severe somatic or neurological diseases, including intracranial hypertension, uncontrolled severe hypertension, bleeds or aneurysm, recent myocardial infarction
  • Current or past history of schizophrenia or schizoaffective disorder
  • Clinically relevant abnormalities found in physical examination or routine laboratory screening
  • Pregnancy or breastfeeding
  • Known allergy to study drugs or their components

AI-Screening

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Trial Site Locations

Total: 1 location

1

Pia Baldinger-Melich

Vienna, Austria, 1090

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Comparison of Esketamine/Propofol and Methohexital Anesthesia for ECT | DecenTrialz