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Schizophenia DisorderPhase 4NCT06664138

Comparison of Remimazolam and Etomidate As Induction Agents for Electroconvulsive Treatment

A Phase 4 study testing Remimazolam and Etomidate in people with Schizophenia Disorder and Major Depression Disorders, run by Yeongseok Yun at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to find if patients would awaken quickly after electroconvulsive treatment when remimazolam is used compared to etomidate. It will also learn about the efficacy of remimazolam. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Remimazolam and Etomidate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSouth Korea
Study dates
28 Apr 2023to 31 Jan 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18-70 years
  • Patients diagnosed with major depression, schizophrenia, and schizoaffective disorder who are scheduled to undergo ECT treatment

Who cannot join

  • American Society of Anesthesiologists Physical Status ≥3
  • Age <18 or >70 years
  • Patients with cognitive impairments, such as dementia or delirium

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Dankook University Hospital

    Cheonan, 31116

Other trials in South Korea

About this study

The goal of this clinical trial is to find if patients would awaken quickly after electroconvulsive treatment when remimazolam is used compared to etomidate. It will also learn about the efficacy of remimazolam. The main questions it aims to answer are:

Will using remimazolam as an induction agent for ECT provide sufficient therapeutic effects? Additionally, when compared to etomidate, will remimazolam lead to a quicker return of spontaneous respiration and faster eye opening after the seizure?

Read more

Participants will:

Remimazolam and etomidate will be used in a random order, each administered once for the induction of anesthesia in ECT.

Blood pressure, heart rate, and other vital signs will be monitored during the treatment, and the duration of the seizure as well as the shock energy used to induce the seizure will be recorded.

Read the detailed description

Patients who underwent ECT under general anesthesia between April 2023 and January 2024 were included. The exclusion criteria were as follows: (1) American Society of Anesthesiologists Physical Status ≥3; (2) age <18 or >70 years; and (3) patients with cognitive impairments, such as dementia or delirium. The study sample comprised 30 patients aged 18-70 years who were scheduled to undergo ECT for major depression, schizophrenia, and schizoaffective disorder. The sample size was calculated using G*Power to compare the recovery times between the two groups. On the basis of an effect size of 0.7 obtained from a previous pilot study and a significance level of 0.05, investigators derived a total sample size of 28. Considering a follow-up loss rate of approximately 10%, investigators designed the study to include a total of 30 participants.

The patients were divided into two groups of 15 each and randomly assigned to ei-ther group E or group R using a computer-generated random number table. To minimize variability in recovery speed and response to medication between individuals, investigators devised a crossover study design in which etomidate and remimazolam were administered alternately, with each drug administered once. Patients in group E received etomidate as the induction agent for the first ECT session, followed by remimazolam for the second ECT session a few days later. Conversely, patients in group R received remimazolam as the induction agent for the first ECT session and etomidate for the second ECT session a few days later. The patients and raters were blinded to the administered anesthetic drugs. Blinding was implemented using opaque sealed envelopes that were sequentially numbered.

ECT was conducted following the international standards approved by our institu-tion, using the SpECTrum 5000 Q device (MECTA Corporation, Lake Oswego, OR, USA).

No premedication was administered, and all patients were required to maintain nil per os for at least 8 h before the procedure. During each ECT session, all patients un-derwent non-invasive blood pressure measurement, electrocardiogram, and peripheral oxygen saturation (SpO2) monitoring, and received preoxygenation through an O2 facial mask before anesthesia.

For neuromuscular blockade, succinylcholine (0.8-1.2 mg/kg IV) was used. The an-esthetic dosages were etomidate at 0.15-0.20 mg/kg IV and remimazolam at 0.12-0.15 mg/kg IV. Following admission and monitoring of the patient, preoxygenation was per-formed until SpO2 reached 100%. Then, the induction agent, either etomidate or remi-mazolam, was administered, immediately followed by 100 mcg of remifentanil. Once the patient stopped responding on being called, a cuff was placed on one arm and inflated until the radial artery pulse was no longer detectable. After isolating one arm, succinyl-choline was administered and sufficient time was allowed for fasciculation to resolve before proceeding. After adequate time for the muscle relaxant to take effect, electrical currents were delivered to the brain through electrodes placed on the scalp. The intensity of the current was determined according to an established psychiatric protocol, and in the absence of a seizure, was increased by 10 J in three successive attempts. If a seizure lasting longer than 30 s was induced, the treatment was considered successful. The duration of the seizure and corresponding shock intensity were recorded for each patient.

Following the seizure, mask ventilation was continued until spontaneous respiration returned. The time from the end of the seizure until the patient's spontaneous tidal volume reached ≥200 mL was measured and defined as the self-respiration recovery time. Additionally, the time from the end of the seizure until the patient opened their eyes spontaneously, either in response to a gentle tap or verbal stimulation, was measured and defined as the eye-opening recovery time.

Apart from the induction agent, there were no differences between the two groups in terms of procedural techniques, anesthetic management during surgery, or cardiovascular support.

Being tested
Remimazolam, Etomidate
Medical subject headings
Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemimazolamDrug

    Remimazolam is a recently approved medication used for the induction of general anesthesia and maintenance of sedation. There have been no prior studies using remimazolam for the induction of anesthesia in ECT, and this research aims to investigate the feasibility of using remimazolam as an induction agent for ECT.

  • EtomidateDrug

    Etomidate is widely used in ECT due to its rapid onset, stable hemodynamic profile, and quick recovery. In this study, remimazolam will be used as the experimental group, while etomidate will serve as the control group.

Study groups in NCT06664138
Study groupRoleWhat they receive
Group Etomidate & RemimazolamOtherPatients will receive both etomidate and remimazolam once each to compare their effects while minimizing individual differences in response to the medications. Group E will use etomidate first, followed by remimazolam in the subsequent session.
Receives: Drug: Remimazolam; Drug: Etomidate
Group Remimazolam & EtomidateOtherPatients will receive both etomidate and remimazolam once each to compare their effects while minimizing individual differences in response to the medications. Group R will use remimazolam first, followed by etomidate in the subsequent session.
Receives: Drug: Remimazolam; Drug: Etomidate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self respiration recovery time

    After the induction of anesthesia, a shock is administered to induce a seizure. The time is measured from the end of the seizure until the patient's spontaneous tidal volume exceeds 200 ml.

    Measured: From enrollment to the end of treatment at one week

  2. eye opening recovery time

    After the induction of anesthesia, a shock is administered to induce a seizure. The time is measured from the end of the seizure until the patient's spontaneous eye opening.

    Measured: From enrollment to the end of treatment at one week

Secondary outcomes (4)
  1. Mean Blood pressure

    Mean Blood pressure measured using non-invasive blood pressure, immediately after induction, immediately after shock, and at awakening state, with measurements taken in mmHg

    Measured: From enrollment to the end of treatment at one week

  2. Heartrate

    Heartrate measured using electrocardigram, immediately after induction, immediately after shock, and at awakening state, with measurements taken in bpm(beats per minute)

    Measured: From enrollment to the end of treatment at one week

  3. seizure duration

    The duration of the induced seizure following the administration of the shock, with measurements taken in seconds

    Measured: From enrollment to the end of treatment at one week

  4. shock energy

    The amount of energy delivered by the shock used to induce the seizure with the ECT machine, measured in Joules.

    Measured: From enrollment to the end of treatment at one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2024
  2. Study start28 Apr 2023
  3. Primary completion31 Jan 2024
  4. Study completion31 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06664138
Sponsor's protocol ID
DKUH 2023-02-005-002
Status last verified
Oct 2024
First submitted
25 Oct 2024
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data generated during the study will be shared and can only be provided to individuals with academic purposes, excluding any personal information about the patients, upon request to the principal investigator.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Remimazolam and Etomidate in people with Schizophenia Disorder and Major Depression Disorders, run by Yeongseok Yun at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self respiration recovery time (time frame: From enrollment to the end of treatment at one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

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