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.
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
- Conditions the study is for
- Schizophenia Disorder, Major Depression Disorders, Schizoaffective Disorder
- 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.
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 group | Role | What they receive |
|---|---|---|
| Group Etomidate & Remimazolam | Other | Patients 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 & Etomidate | Other | Patients 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.
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
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)
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
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
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
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.
- First posted29 Oct 2024
- Study start28 Apr 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophenia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Yeongseok Yun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yeongseok Yun, Dankook University
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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Remimazolam and Etomidate As Induction Agents for Electroconvulsive Treatment
- ClinicalTrials.gov ID
- NCT06664138
- Acronym / sponsor ID
- DKUH 2023-02-005-002
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yeongseok YunUniversity, hospital or other
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Etomidate & Remimazolam | Other | Drug: Remimazolam, Drug: EtomidatePatients 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. |
| Group Remimazolam & Etomidate | Other | Drug: Remimazolam, Drug: EtomidatePatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18-70 years
- Patients diagnosed with major depression, schizophrenia, and schizoaffective disorder who are scheduled to undergo ECT treatment
Key exclusion criteria (3 listed)
- American Society of Anesthesiologists Physical Status ≥3
- Age <18 or >70 years
- Patients with cognitive impairments, such as dementia or delirium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemimazolamRemimazolam 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. | Drug | Group Etomidate & Remimazolam, Group Remimazolam & Etomidate |
| EtomidateEtomidate 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. | Drug | Group Etomidate & Remimazolam, Group Remimazolam & Etomidate |
Primary outcome
Self respiration recovery time
Time frame: From enrollment to the end of treatment at one week
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.
eye opening recovery time
Time frame: From enrollment to the end of treatment at one week
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.
4 secondary outcomes
Mean Blood pressure
Time frame: From enrollment to the end of treatment at one week
Heartrate
Time frame: From enrollment to the end of treatment at one week
seizure duration
Time frame: From enrollment to the end of treatment at one week
shock energy
Time frame: From enrollment to the end of treatment at one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.