Effects of Ciprofol Anesthesia on Learning and Memory Function and Antidepressant Effects of ECT in Depressive Patients

Chongqing Medical University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Depressive Disorder

Treatments: Drug: Propofol; Drug: ciprofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05266560

C-ECT20220214

Details and patient eligibility

About

In this clinical study, propofol was used as the positive control, and a randomized controlled trial design was used to observe the effects of ciprofol anesthesia on learning and memory function and antidepressant efficacy in patients with ECT. A total of 390 depressed patients who were to undergo electroconvulsive therapy were selected and randomly divided into two groups, namely the propofol group (n=195 cases) and the ciprofol group (n=195 cases). The patients in the propofol group were given propofol 1.5mg/kg + succinylcholine 1mg/kg, and the patients in the ciprofol group were given ciprofol 0.4mg/kg and succinylcholine 1mg/kg, and the patients were given electroshock after anesthesia treat.

Full description

Ciprofol injection, whose active component (HSK3486) is propofol analogue, is a novel treatment for anesthesia induction and maintenance. It has been authorized for commercialization in China on December 14, 2020.

The purpose of this experiment is to know the effect of ciprofol on the antidepressant effect and cognitive function of depressive patients after electroconvulsive therapy. Ciprofol is very similar in structure to propofol, so propofol was used as the control group in this experiment.

Enrollment: 390 estimated patients

Sex: All

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Depressed patients who plan to receive MECT.
2. Meet the diagnostic criteria of DSM-IV depression
3. 16≤age≤45 years old, gender is not limited
4. ASA score is I or II
5. The depressive episode lasted for at least 2 weeks
6. Clearly understand and voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

1. Combined with serious physical diseases, such as uncontrolled hypertension, coronary heart disease, intracranial vascular malformations, asthma attacks, severe liver and kidney dysfunction, etc.
2. Foreign bodies in the body: such as pacemakers, intracranial electrodes, etc.
3. Those who have a history of epilepsy
4. Those who are taking reserpine
5. Those with acute and systemic infectious diseases, with moderate or higher fever
6. Those with a history of manic episodes
7. Those with anesthetics, Allergic to muscle relaxants
8. Pregnant women
9. Glaucoma
10. Bipolar disorder, or combined with other mental illnesses, mental retardation
11. Those who are judged not suitable for MECT treatment by the competent physician
12. History of drug abuse

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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390 participants in 2 patient groups

Propofol injection group (1.5mg/kg)

Active Comparator group

Description:

The patients in the propofol group were given intravenous injection of propofol 1.5 mg/kg and succinylcholine 1 mg/kg in turn, and the interval between each drug administration was 1 minute, and electroconvulsive therapy was performed after the patients were anesthetized.

Treatment:

Drug: Propofol

Ciprofol injection group(0.4mg/kg)

Experimental group

Description:

The patients in the ciprofol group were given intravenous injection of ciprofol 0.4 mg/kg and succinylcholine 1 mg/kg in turn. The interval between each drug administration was 1 minute, and the patients received electroconvulsive therapy after anesthesia.

Treatment:

Drug: ciprofol