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

Sponsor
First Affiliated Hospital of Chongqing Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05266560
Collaborator
(none)
390
Enrollment
2
Arms
34
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
390 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Effects of Ciprofol Anesthesia on Learning and Memory Function and Antidepressant Efficacy of ECT in Patients With Depression
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • First Affiliated Hospital of Chongqing Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Min Su, Professor.Min, First Affiliated Hospital of Chongqing Medical University
    ClinicalTrials.gov Identifier:
    NCT05266560
    Other Study ID Numbers:
    • C-ECT20220214
    First Posted:
    Mar 4, 2022
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Depressive Disorder
    Propofol

    Study Results

    No Results Posted as of Mar 4, 2022