Depressive Disorder
Conditions
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.
Interventions
DRUGciprofol
A new type of anesthetic drug, Ciprofol, which is newly listed and has national independent intellectual property rights, is an analogue of propofol. Its chemical name is 2-\[(1R)-1-cyclopropylethyl\]-6-isopropyl-phenol, and it acts on GABAA receptors like propofol. Compared with propofol, ciprofol is 4-5 times more potent, which can significantly reduce the amount of anesthetics.
DRUGPropofol
Propofol is a commonly used anesthetic in clinical practice and is often used before ECT.
Sponsors
First Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive impairment rate within 24 hours after the whole ECT course | After the patient received MECT treatment within 24 hours after the whole ECT course | Percentage of patients with cognitive impairment within 24 hours after the whole ECT course |
Outcome results
None listed