Effect of Subanesthetic Dose of Ketamine Combined With Propofol on Cognitive Function in Depressive Patients Undergoing Electroconvulsive Therapy

Ketamine

Brief Summary

Electroconvulsive therapy (ECT) is an effective treatment for depression compared with the current antidepressant agents，but the most important side effect is cognitive dysfunction. The purpose of this study is to determine whether subanesthetic dose of ketamine combined with propofol is superior to propofol anesthesia alone in improving cognitive function in depressive patients undergoing ECT.

Intervention / Treatment

  • ketamine and propofol (DRUG)
    propofol 1.5 mg/kg and ketamine 0.3 mg/kg will be administered to participants separately by intravenous infusion.
  • propofol and normal saline (DRUG)
    propofol 1.5 mg/kg and normal saline \[weight(kg)×0.3÷10\]ml will be administered to participants separately by intravenous infusion.

Condition or Disease

  • Depressive Symptoms
  • Impaired Cognition
  • Electroconvulsive Therapy

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 132 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jan 01, 2015
    Primary Completion: Dec 01, 2016 ESTIMATED
    Completion Date: Feb 01, 2017 ESTIMATED
    Study First Posted: Dec 02, 2014 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Dec 01, 2014

    Sponsors / Collaborators

    Lead Sponsor: First Affiliated Hospital of Chongqing Medical University
    Responsible Party: N/A

    Location

    Chongqing, China

    Depression is one of the most debilitating and widespread illnesses affecting up to 20% of individuals in their lifetime. However, the current antidepressant agents take weeks to work, and fail to help at least 40% of depressed patients. Electroconvulsive therapy (ECT) is a remarkably effective treatment for depression, but its use is limited by cognitive dysfunction.

    As a result, it is becoming a clinical problem which need to be settled urgently. Previous clinical study showed that subanesthetic dose of ketamine could play a role in antidepressant effects with safety and minimal positive psychotic symptoms.The investigators also found that subanesthetic dose of ketamine combined with other anesthetics could improve cognitive function in depressive rats receiving electroconvulsive shock (a model for analogy with ECT). Few clinical researches concerned the effects of subanesthetic dose of ketamine combined with propofol anesthesia on cognitive function in patients after ECT, therefore the investigators conduct this randomized controlled double-blind trial. In this study, cognitive function will be rated by Mini-Mental State examination score.

    Participant Groups

    • propofol 1.5 mg/kg and ketamine 0.3 mg/kg will be administered to participants separately by intravenous infusion.When patients become unconscious, succinylcholine 1 mg/kg (a muscle relaxant) will be administered intravenously. After 1 minute of succinylcholine infused, ECT will be performed with bitemporal electrode placement using a stimulus dose of 1.0-millisecond pulse width, 60-Hz frequency, 6.0-second stimulus duration, and 0.8-A maximal stimulus intensity.

    • propofol 1.5 mg/kg and normal saline \[weight(kg)×0.3÷10\]ml will be administered to participants separately by intravenous infusion.When patients become unconscious, succinylcholine 1 mg/kg (a muscle relaxant) will be administered intravenously. After 1 minute of succinylcholine infused, ECT will be performed with bitemporal electrode placement using a stimulus dose of 1.0-millisecond pulse width, 60-Hz frequency, 6.0-second stimulus duration, and 0.8-A maximal stimulus intensity.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    1. diagnosed with moderate or severe depression according to Diagnostic and Statistical Manual of Mental Disorders
    2. aged from 18 to 65 years old

    Exclusion Criteria:

    1. cerebrovascular malformation, arterial aneurysm, hypertension, or glaucoma;
    2. classification of American Society of Anesthesiologists physical status score IV or V;
    3. complications such as respiratory disease, cardiovascular disease, intracranial hypertension, cerebral vascular disorder;
    4. presence of a foreign body such as pacemaker, intracranial electrode, and clips;
    5. history of seizures;
    6. history of drug abuse;
    7. concomitant presence of a mental disorder;
    8. pregnancy;
    9. history of serious adverse effects related to anesthetics;
    10. refusal to consent for the study, or refusal to undergo one single ECT during the first week of therapy.
    11. hyperthyreosis

    Primary Outcomes

    • Mini-Mental State examination score will be measured at 24 hours after the sixth ECT.

    Secondary Outcomes

    • Mini-Mental State examination score will be measured at 24 hours before the first ECT and 24 hours after each ECT, except the sixth ECT.

    • Effect on antidepression will be measured by 24-item Hamilton Depression Rating Scale(HDRS)

    • Seizure duration and Seizure energy index will be recorded by the ECT apparatus.

    • Brief Psychiatric Rating Scale is related to psychotomimetic side-effect.

    • Adverse effects include nausea, vomit, headache, tachycardia and increased blood pressure.

    More Details

    NCT Number: NCT02305394
    Other IDs: CYYYMZ-006
    Study URL: https://clinicaltrials.gov/study/NCT02305394
    Last updated: Sep 29, 2023