Clinical trial NCT05266560: Effects of Ciprofol Anesthesia on Learning and Memory Function and Antidepressant Effects of ECT in Depressive Patients
Official title: Effects of Ciprofol Anesthesia on Learning and Memory Function and Antidepressant Efficacy of ECT in Patients With Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Depressive Disorder
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 390
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive impairment rate within 24 hours after the whole ECT course
timeFrame: After the patient received MECT treatment within 24 hours after the whole ECT course
Secondary outcomes:
Other outcomes:
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