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

NCT05266560 | Unknown Early Phase 1

• 1 other identifier: C-ECT20220214
• Study Type: interventional
• Target: 390
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Propofol injection group (1.5mg/kg)

ACTIVE COMPARATOR

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

Ciprofol injection group(0.4mg/kg)

EXPERIMENTAL

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

Interventions

ciprofol 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.

Also known as: 2-[(1R)-1-cyclopropylethyl]-6-isopropyl-phenol

Ciprofol injection group(0.4mg/kg)

Propofol DRUG

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

Also known as: 2,6-Diisopropylphenol

Propofol injection group (1.5mg/kg)

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Depressed patients who plan to receive MECT.
• Meet the diagnostic criteria of DSM-IV depression
• ≤age≤45 years old, gender is not limited
• ASA score is I or II
• The depressive episode lasted for at least 2 weeks
• Clearly understand and voluntarily participate in the study and sign the informed consent form.

You may not qualify if:

• Combined with serious physical diseases, such as uncontrolled hypertension, coronary heart disease, intracranial vascular malformations, asthma attacks, severe liver and kidney dysfunction, etc.
• Foreign bodies in the body: such as pacemakers, intracranial electrodes, etc.
• Those who have a history of epilepsy
• Those who are taking reserpine
• Those with acute and systemic infectious diseases, with moderate or higher fever
• Those with a history of manic episodes
• Those with anesthetics, Allergic to muscle relaxants
• Pregnant women
• Glaucoma
• Bipolar disorder, or combined with other mental illnesses, mental retardation
• Those who are judged not suitable for MECT treatment by the competent physician
• History of drug abuse

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

MeSH Terms

Conditions

Depressive Disorder

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; Propofol

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor.Min

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 4, 2022
• Study Start: March 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 31, 2024
• Last Updated: March 4, 2022

Record last verified: 2022-02