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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depressive Disorder
• Intervention / Treatment: Drug: Propofol; Drug: ciprofol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 390
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 41 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Propofol; Propofol is a commonly used anesthetic in clinical practice and is often used before ECT.; Other Names: 2,6-Diisopropylphenol
Experimental: 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.	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.; Other Names: 2-[(1R)-1-cyclopropylethyl]-6-isopropyl-phenol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: C-ECT20220214

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No