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

NCT ID: NCT05266560

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-12-31

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.

Conditions

Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Propofol injection group (1.5mg/kg)

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.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Propofol is a commonly used anesthetic in clinical practice and is often used before ECT.

Ciprofol injection group(0.4mg/kg)

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.

Group Type: EXPERIMENTAL

ciprofol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Propofol

Propofol is a commonly used anesthetic in clinical practice and is often used before ECT.

Intervention Type: DRUG

Other Intervention Names

2-[(1R)-1-cyclopropylethyl]-6-isopropyl-phenol; 2,6-Diisopropylphenol

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Min Su

Professor.Min

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

C-ECT20220214

Identifier Type: -

Identifier Source: org_study_id