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

Depressive Disorder Clinical Trial

Official title:

Effects of Ciprofol Anesthesia on Learning and Memory Function and Antidepressant Efficacy of ECT in Patients With Depression

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05266560
• Other study ID #: C-ECT20220214
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: March 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2022
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 390
• Est. completion date: December 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder

Intervention

Drug:
• ciprofol
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.
• Propofol
Propofol is a commonly used anesthetic in clinical practice and is often used before ECT.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive impairment rate within 24 hours after the whole ECT course	Percentage of patients with cognitive impairment within 24 hours after the whole ECT course	After the patient received MECT treatment within 24 hours after the whole ECT course