A study of effectiveness of Remimazolam in Modified Electroconvulsive Therapy

JRCT ID: jRCT1030240216

Registered date:12/07/2024

Basic Information

• Recruitment status: Pending

Health condition(s) or Problem(s) studied

Drug-resistant depression
Schizophrenia

• Date of first enrollment: 12/07/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Patients will be randomly assigned to remimazolam besilate or propofol groups, each receiving the two drugs at the time of mECT treatment. Delirium will be assessed with the 4AT-J before and after treatment.

Outcome(s)

• Primary Outcome: 4AT-J(Immediately after surgery)

Secondary Outcome

Induction time, hemodynamic changes, seizure duration, recovery time, incidence of vomiting reflex, cough, and tears during anesthesia induction
4AT-J (morning of treatment day, 1 hour after treatment, 3 hours after treatment, morning of next day after treatment)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable

Include criteria

1)Patients admitted to the Mental Care Center Ward of Showa University Northern Yokohama Hospital and undergoing mECT
2)Patients with ASA-PS2 and 3
3)Persons who have obtained written consent to participate in this study from the individual or a surrogate
4)Those who are judged to be eligible for participation in this study by the physician in charge of the study, etc. in the pre-test specified in the protocol of this study

Exclude criteria

1) Patients with intracranial hypertension, cerebral aneurysm, recent myocardial infarction (within 3 months), angina pectoris, congestive heart failure
2) Patients with bronchial asthma
3) Patients with neuromuscular disease
4) Patients with a history of hypersensitivity to remimazolam besilate, propofol itself or its components, acute angle closure glaucoma, myasthenia gravis, shock, coma, or acute alcohol intoxication with suppressed vital signs
5) Patients within 3 months of participation in other clinical research
6) Other patients who are judged by the investigator to be ineligible for this study.

Related Information

• Primary Sponsor: Shimono Shinako