Comparison of Remimazolam and Etomidate As Induction Agents for Electroconvulsive Treatment

NCT06664138 | Completed Phase 4

• 1 other identifier: DKUH 2023-02-005-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Schizophenia Disorder; Major Depression Disorders; Schizoaffective Disorder; Bipolar

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From enrollment to the end of treatment at one week

Secondary Outcomes (4)

• Mean Blood pressure

  From enrollment to the end of treatment at one week

• Heartrate

  From enrollment to the end of treatment at one week

• seizure duration

  From enrollment to the end of treatment at one week

• shock energy

  From enrollment to the end of treatment at one week

Study Arms (2)

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.

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.

Drug: Remimazolam; Drug: Etomidate

Interventions

Remimazolam DRUG

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.

Group Etomidate & Remimazolam; Group Remimazolam & Etomidate

Etomidate DRUG

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.

Group Etomidate & Remimazolam; Group Remimazolam & Etomidate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yeongseok Yun: lead

Study Sites (1)

Dankook University Hospital

Cheonan, 31116, South Korea

Location

MeSH Terms

Conditions

Psychotic Disorders

Interventions

remimazolam; Etomidate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator at Dankook University

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 29, 2024
• Study Start: April 28, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

KR (1)